[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":422},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,75,96,122,142,165,187,210,231,257,283,303,319,335,350,372,396],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100633048","one-stop-diagnosis-and-treatment-for-suspected-lung-cancer-combined-rbs-ncle-obct-and-ablation-100633048",false,"NCT07521618","One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation","An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System","One-stop","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* High-risk pulmonary nodule\u002Ftumor maximum diameter ≤3 cm.\n* Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.\n* Ineligible for surgery or refuses surgery\u002Fradiotherapy; agrees to primary ablation therapy; provides written informed consent.\n\nExclusion Criteria:\n\n* Diffuse bilateral lung lesions unresponsive to ablation.\n* Contraindication to bronchoscopy or inability to tolerate\u002Fcooperate with bronchoscopy.\n* Severe bleeding tendency or irreversible coagulopathy (PT \\>18 s, PTA \\\u003C40%).Platelet count \\\u003C70×10⁹\u002FL; anticoagulant\u002Fantiplatelet therapy discontinued \\\u003C1 week before ablation (except prophylactic low-molecular-weight heparin).\n* Severe pulmonary impairment (maximal voluntary ventilation \\\u003C40%).\n* Other metastatic tumors with widespread metastasis; life expectancy \\\u003C3 months.\n* Poor general condition: widespread metastasis, severe infection, high fever, infectious\u002Fradiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic\u002Fnutritional disorders.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n* Target lesion received radiotherapy within the past 6 months.\n* Active hepatitis B, active hepatitis C, known HIV-1\u002F2 antibody positivity, or other active infections judged by the investigator to interfere with treatment.\n* History of epilepsy, psychosis, or cognitive impairment.\n* Pregnant\u002Flactating females; males or females planning conception during the trial.\n* Other conditions deemed inappropriate by the investigator.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.",[27,28,29,30],"Lung Cancer (Suspected or Confirmed)","Cryoablation","Robotic Bronchoscopy System","Confocal Laser Endomicroscopy","NOT_YET_RECRUITING","2026-04-08",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":21},"2026-04-01",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Guangzhou Medical University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100538892","phase-2-intrathecal-pemetrexed-for-leptomeningeal-metastasis-from-lung-adenocarcinoma-that-progressed-after-osimertinib-100538892","NCT06296745","Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.","An Open-label, Single-arm, Phase II Trial of Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After a Double Dose of Third-generation TKIs, Including Osimertinib","Inclusion Criteria:\n\n1. Male or female aged between 18 and 75 years.\n2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del).\n3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO\u002F EANO guidelines.\n4. Progression after previous double doses of third-generation TKIs such as Osimertinib.\n5. Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n6. No history of severe nervous system disease.\n7. No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. Patients with poor compliance or other reasons that were unsuitable for this study","75 Years",{"count":52,"type":21},36,[54],"PHASE2","Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R\u002FT790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib.",[57],"Leptomeningeal Metastasis",[59,60,61,62,63,64],"Leptomeningeal metastasis","Intrathecal chemotherapy","Pemetrexed","Osimertinib","Epidermal growth factor receptor mutation","Non-small-cell lung cancer","RECRUITING","2026-01-28",{"date":68,"type":35},"2026-01-30",{"date":70,"type":35},"2025-09-01",{"date":72,"type":21},"2027-03-20",{"name":41,"class":42},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":95,"locationsCount":74},"100620019","study-on-the-effectiveness-and-safety-of-cle-combined-with-cryobiopsy-for-diagnosis-of-pulmonary-lesions-100620019","NCT07352176","Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions","Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions","Inclusion Criteria:\n\n1. Patients over 18 years old with lung lesions indicated by chest CT;\n2. Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;\n3. Able to understand and voluntarily sign the written informed consent form. -\n\nExclusion Criteria:\n\n1. Patients with contraindications to anesthesia or bronchoscopy;\n2. Patients with uncorrectable coagulation disorders;\n3. Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;\n4. Patients with severe liver or kidney dysfunction, mental illness, etc.;\n5. Pregnant or lactating patients;\n6. Patients without a clear histological or clinical diagnosis;\n7. Subjects deemed unsuitable for participation in this study by the investigator.",{"count":83,"type":21},40,[24],"Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound\u002Fconfocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.",[87,88],"Pulmonary Lesion","Lung Cancer","2026-01-11",{"date":91,"type":35},"2026-01-20",{"date":93,"type":21},"2026-02-01",{"date":39,"type":21},{"name":41,"class":42},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":74},"100551592","phase-1-sacituzumab-govitecan-and-intrathecal-chemotherapy-for-treating-leptomeningeal-metastases-from-her2-negative-breast-cancer-100551592","NCT06462092","Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer","A Phase I\u002FII Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer","Inclusion Criteria:\n\n1. A clear histopathologic diagnosis of breast cancer with HER2-negative subtype (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);\n2. Cerebrospinal fluid cytology confirms the presence of leptomeningeal metastases; or imaging findings combined with clinical symptoms and signs are consistent with the diagnosis of leptomeningeal metastases;\n3. Age ≥ 18 years old.\n\nExclusion Criteria:\n\n1. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10\\^9\u002FL, PLT ≤ 90 x 10\\^9\u002FL, Hb ≤ 90 g\u002FL; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;\n2. Presence of serious and\u002For uncontrolled comorbidities that may affect participation: 1) Allergy to study drugs or adjuvant materials; 2) History of immunodeficiency (e.g., HIV-positive or other acquired or congenital immunodeficiency disease); 3) Severe concomitant diseases;\n3. Pregnant and breastfeeding female patients; women of childbearing age who are unwilling or unable to use effective contraception;\n4. Any other condition that, in the opinion of the investigator, makes the patient ineligible for participation in the study.",{"count":104,"type":21},34,[106,54],"PHASE1","Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I\u002FII clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.",[109],"Leptomeningeal Metastases",[111,112,109,113,61,60],"Breast cancer","Her2- (Human Epidermal Growth Factor Receptor 2 Negative)","Sacituzumab Govitecan","2025-09-24",{"date":116,"type":35},"2025-09-29",{"date":118,"type":21},"2026-01-01",{"date":120,"type":21},"2027-06-15",{"name":41,"class":42},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":74},"100539484","intra-pemetrexed-plus-third-generation-small-molecule-tki-drugs-eg-osimertinib-versus-third-generation-small-molecule-tki-drugs-alone-for-leptomeningeal-metastasis-from-epidermal-growth-factor-receptor-mutation-positive-non-small-cell-lung-cancer-100539484","NCT06304441","Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer","A Clinical Trial of Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female aged between 18 and 75 years.\n2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del).\n3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO\u002FEANO guidelines.\n4. Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n5. No history of severe nervous system disease.\n6. No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. Patients with poor compliance or other reasons that were unsuitable for this study.",{"count":130,"type":21},100,[24],"Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R\u002FT790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined.",[57],[59,60,61,135,62,63],"Third-generation small molecule TKI drugs",{"date":116,"type":35},{"date":138,"type":35},"2024-04-18",{"date":140,"type":21},"2026-09",{"name":41,"class":42},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100597025","diagnostic-efficiency-comparasion-of-hand-drawn-navigation-and-virtual-navigation-for-peripheral-pulmonary-nodules-100597025","NCT07053124","Diagnostic Efficiency Comparasion of Hand-Drawn Navigation and Virtual Navigation for Peripheral Pulmonary Nodules","Diagnostic Efficiency Comparation of Hand-Drawn Navigation and Virtual Navigation for Peripheral Pulmonary Nodules: A Prospective, Randomized, Parallel-Controlled, Global Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age≥18 years;\n2. Patients with pulmonary nodule and nodule size \\>8mm but ≤ 30mm, bronchus level of the nodule ≥ grade 5, who are scheduled to undergo bronchoscopy biopsy for definitive diagnosis;\n3. In the judgment of investigator that the nodule is difficult to reach with conventional bronchoscopy and bronchoscopy guidance technology is needed.\n\nExclusion Criteria:\n\n1. Contraindications for bronchoscopy examination;\n2. Other situations what investigators consider inappropriate for participation.1.Contraindications for bronchoscopy examination; Other situations what investigators consider inappropriate for participation.",{"count":150,"type":21},500,[24],"Peripheral pulmonary lesions (PPLs) refer to isolated or localized lesions located in the outer one-third of the lung field. Their qualitative diagnosis is a key link in the early screening and precise treatment of lung cancer. However, due to the deep location, small size (especially those with diameters \\\u003C 2 cm), and unclear relationship with bronchi of peripheral pulmonary lesions, traditional bronchoscopy is difficult to directly reach the lesion, resulting in a relatively low positive rate of biopsy. Moreover, although conventional imaging examinations (such as CT) can locate the lesions, they cannot provide a histological diagnostic basis. Percutaneous puncture under CT guidance has high risks such as pneumothorax, bleeding and pleural reaction, and has low efficiency in locating multiple lesions.\n\nAt present, there are various auxiliary techniques for the diagnosis of peripheral pulmonary nodules, each with its own advantages and disadvantages:\n\n1. Image-guided techniques: Although traditional CT-guided percutaneous biopsy is intuitive in terms of localization, it has high complication risks and limited applicability for nodules close to the mediastinum or blood vessels.\n2. Radial Bronchial Endobronchial Ultrasound (RP-EBUS): Combined with a guide sheath (GS), it can increase the positive rate of peripheral nodule biopsy (the weighted diagnostic rate without fluoroscopy can reach 70%), but it relies on the operator's familiarity with bronchial anatomy and is difficult to solve complex bronchial path planning problems alone.\n3. Virtual Bronchoscopy Navigation (VBN): VBN generates virtual bronchial paths based on CT three-dimensional reconstruction, significantly shortening the operation time and improving the diagnostic rate (62.5%-84.4%, overall 73.8%). However, its limitations are obvious: it relies on high-quality CT images and is sensitive to respiratory motion artifacts; it cannot be adjusted in real time, and during the operation, it is prone to deviate from the navigation map due to anatomical variations or secretions, with high equipment costs and difficulty in popularization in grassroots hospitals.\n4. Electromagnetic Navigation Bronchoscopy (ENB): ENB achieves precise navigation through electromagnetic positioning, with a diagnostic rate of up to 70%-80%, but the equipment is expensive (single consumable cost is about 1-20,000 yuan), and it needs to be combined with intraoperative fluoroscopy.\n5. Robotic-assisted bronchoscopy navigation: Emerging technologies such as robotic-assisted navigation offer good stability and high precision in control, but they are complex in terms of technology and expensive in terms of equipment. Currently, they are only available in large medical centers in China.\n\nHand-drawn Mapping Navigation is a manual drawing technique based on preoperative CT images. By marking the directions of bronchial branches and the positions of nodules, it provides the surgeons with intuitive path planning. Studies have shown that hand-drawn navigation combined with RP-EBUS can shorten the time for bronchoscopy to reach the biopsy site from 8.89 ± 4.09 minutes to 6.32 ± 3.10 minutes (P \\\u003C 0.001), and bronchial grading and hand-drawn navigation are independent influencing factors. Compared with VBN, its advantages lie in: low cost, only requiring pen and paper or electronic drawing tools, high flexibility, and the ability to adjust the path in real time in combination with the surgeon's experience; no reliance on complex software or hardware equipment, suitable for areas with limited resources. Currently, there have been many studies exploring the clinical value of hand-drawn mapping navigation maps and comparing them with VBN. However, most of the existing studies are limited to single-center retrospective analyses and lack prospective control evidence compared with VBN.\n\nThis study aims to compare the clinical application value of hand-drawn navigation and VBN in the diagnosis of peripheral pulmonary nodules through a randomized controlled trial. The main objective is to evaluate the differences in clinical application between the hand-drawn navigation group and the VBN group in terms of bronchoscopy arrival time, positive biopsy rate, and complication occurrence rate; analyze the applicability of the two techniques in different bronchial grade nodules, etc. The study results will provide evidence-based basis for optimizing the diagnosis and treatment pathway of peripheral pulmonary nodules and lay a foundation for the development of low-cost precise navigation technology.",[154],"Peripheral Pulmonary Nodules",[156],"Peripheral pulmonary nodules","2025-07-06",{"date":159,"type":35},"2025-07-08",{"date":161,"type":21},"2025-07-01",{"date":163,"type":21},"2026-07-31",{"name":41,"class":42},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":186,"locationsCount":74},"100593323","diagnostic-value-of-confocal-laser-endomicroscopy-celtouch-for-peripheral-lung-lesions-100593323","NCT07004946","Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions","Inclusion Criteria:\n\n1. Aged ≥18 years, with lung lesions detected by chest CT and scheduled for lung biopsy;\n2. Preoperative CT indicates the presence of a bronchus leading to the lesion to be biopsied;\n3. Able to understand and willing to sign a written informed consent form. -\n\nExclusion Criteria:\n\n1. Those with contraindications to general anesthesia or bronchoscopy;\n2. Patients with uncorrectable coagulation disorders;\n3. Unable to discontinue therapeutic anticoagulants within an appropriate time interval before surgery;\n4. Patients with severe liver or kidney dysfunction, cardiovascular and cerebrovascular diseases, mental illnesses, etc.;\n5. Pregnant or lactating patients;\n6. Those without a clear histological or clinical diagnosis;\n7. Subjects deemed unsuitable by the investigator. -","80 Years",{"count":173,"type":21},286,"OBSERVATIONAL","This study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung lesions will be validated through multicenter clinical research; and a CLE atlas for peripheral lung lesions will be constructed to establish a visual classification diagnostic system for peripheral lung lesions.\n\n(1) Comparative Study of In Vivo CLE Images and Pathological Images in the Diagnosis of Peripheral Lung Lesions\n\n1. Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions.\n2. A diagnostic team composed of 1 bronchoscopy expert, 1 pathology expert, and 2 CLE experts will correlate in vivo and ex vivo CLE images of lung lesions with corresponding pathological images, analyze CLE image characteristics of benign and malignant lung lesions, and establish CLE diagnostic criteria for benign and malignant lung lesions.\n\n(2) Validation Study of the Diagnostic Performance of Confocal Laser Endomicroscopy in Peripheral Lung Lesions\n\n1. Multicenter screening of corresponding subjects according to inclusion and exclusion criteria, collection of corresponding videos and images during surgery, and recording of observed characteristic images based on pre-established diagnostic characteristics and criteria.\n2. The diagnostic team and sub-center representatives (5 in total) will perform offline interpretation of the collected images and videos, and evaluate the diagnostic performance of CLE in peripheral lung lesions using the accurate diagnostic results obtained from postoperative histopathology or 6-month clinical follow-up as the standard.\n3. Establishment of a CLE Atlas and Classification System for Lung Lesions\n\n(1) Collect large-scale in vivo and ex vivo CLE images and pathological images of clearly diagnosed lung lesions from multiple centers.\n\n(2) Select typical in vivo and ex vivo CLE images of lung lesions with the same pathological type and corresponding pathological images, and jointly describe the CLE image diagnostic characteristics by pathology experts and CLE experts to establish a CLE atlas for peripheral lung lesions.\n\n(3) Establish a visual classification system for the internal structure of peripheral lung lesions based on the special signs in CLE images of lung lesions.",[177],"Peripheral Pulmonary Lesion",[179],"peripheral pulmonary lesion","2025-05-26",{"date":182,"type":35},"2025-06-04",{"date":184,"type":21},"2025-05-31",{"date":39,"type":21},{"name":41,"class":42},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":74},"100574653","phase-1-intrathecal-combination-of-programmed-death-1-pd-1cytotoxic-t-lymphocyte-associated-protein-4-ctla-4-bispecific-antibody-and-pemetrexed-for-leptomeningeal-metastasis-100574653","NCT06762080","Intrathecal Combination of Programmed Death-1 (PD-1)\u002FCytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis","Intrathecal Administration of PD-1\u002FCTLA-4 Bispecific Antibody Plus Pemetrexed in Patients With Leptomeningeal Metastasis From Solid Tumors: A Phase I\u002FII Study","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n4. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against leptomeningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI\u002FALK-TKI drugs like Osimertinib and Lorlatinib.\n5. Patients with poor compliance or other reasons that were unsuitable for this study.",{"count":52,"type":21},[106,54],"Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal Programmed Death-1 (PD-1)\u002FCytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in patients with leptomeningeal metastasis.",[57],[199,200,61,201,57],"Cadonilimab","PD-1\u002FCTLA-4","Intrathecal","2025-05-15",{"date":204,"type":35},"2025-05-20",{"date":206,"type":35},"2025-03-07",{"date":208,"type":21},"2026-06-01",{"name":41,"class":42},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":217,"maxAge":50,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":74},"100578301","phase-1-intrathecal-pd-1vegf-bispecific-antibody-plus-pemetrexed-for-leptomeningeal-metastasis-100578301","NCT06809517","Intrathecal PD-1\u002FVEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis","A Phase I\u002FII Clinical Study of Intrathecal Combination Therapy With the PD-1\u002FVEGF Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors;Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. Obvious bleeding tendency; Patients with hemorrhage (NCI-CTCAE v5.0 greater than grade 2), coagulation disorder, hypertensive crisis, and severe arterial thrombosis.\n4. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n5. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against leptomeningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI\u002FALK-TKI drugs like Osimertinib and Lorlatinib.\n6. Patients with poor compliance or other reasons that were unsuitable for this study.","21 Years",{"count":104,"type":21},[106,54],"Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors.\n\nThis phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal PD-1\u002FVEGF bispecific antibody plus pemetrexed in patients with leptomeningeal metastasis.",[57,222],"Intrathecal Drug Delivery",[59,224,61],"PD-1\u002FVEGF Bispecific Antibody",{"date":204,"type":35},{"date":227,"type":35},"2025-03-18",{"date":229,"type":21},"2026-05-01",{"name":41,"class":42},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":217,"maxAge":50,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100578302","phase-1-intrathecal-dual-checkpoint-inhibitor-pd-1-and-ctla-4-in-combination-with-pemetrexed-for-leptomeningeal-metastasis-100578302","NCT06809530","Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis","Intrathecal Administration of Dual Checkpoint Inhibitor in Combination With Pemetrexed in Patients With Leptomeningeal Metastasis: a Phase I\u002FII Study","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n4. Patients with poor compliance or other reasons that were unsuitable for this study.",{"count":104,"type":21},[106,54],"This phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.",[57,61,242,243,244],"PD-1 Inhibitor","CTLA4","Solid Tumors",[59,246,247],"dual checkpoint inhibitor","pemetrexed","2025-05-14",{"date":250,"type":35},"2025-05-18",{"date":252,"type":35},"2025-03-17",{"date":254,"type":21},"2026-07-01",{"name":41,"class":42},2,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":256},"100571339","a-real-world-study-on-the-treatment-of-non-small-cell-lung-cancer-with-leptomeningeal-metastasis-in-china-100571339","NCT06718972","A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China","Database of Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China","CLM-tree datab","Inclusion Criteria:\n\n* non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;\n* Patients who underwent antitumor therapy after diagnosis of LM.\n\nExclusion Criteria:\n\n* Patients with small cell lung cancer components;\n* complicated with tumors other than non-small cell lung cancer.",{"count":266,"type":21},1000,"This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival\u002FTime to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.",[269,270],"Meningeal Metastasis","Non-Small Cell Lung Cancer",[270,272,273,274],"meningeal metastasis","real-world study","database","2025-04-24",{"date":277,"type":35},"2025-04-27",{"date":279,"type":35},"2024-09-01",{"date":281,"type":21},"2028-12-31",{"name":41,"class":42},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100580104","efficacy-and-safety-of-cryoablation-with-robotic-bronchoscopy-system-in-patients-with-lung-cancer-100580104","NCT06832956","Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer","Inclusion Criteria:\n\n* (1) Age ≥ 18 years old, regardless of gender. (2) Diagnosed with peripheral lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number of tumors ≤ 3. (3) The lesion to be ablated is evaluated as suitable for bronchoscopy-guided cryoablation treatment. (4) The subject refuses or is deemed unsuitable for radiotherapy\u002Fchemotherapy, or shows no response to previous radiotherapy\u002Fchemotherapy, or experiences disease progression after radiotherapy\u002Fchemotherapy. (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment, and signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Diffuse lesions in both lungs where ablation treatment is unlikely to improve the condition. (2) Presence of hilar lymph node metastasis or extrapulmonary metastasis as indicated by examinations within 1 month before the operation (except for extrapulmonary metastasis that has been controlled by local treatment). (3) Presence of contraindications for bronchoscopy, or inability to tolerate or cooperate with bronchoscopy. (4) Severe bleeding tendency, uncorrectable coagulation dysfunction (prothrombin time \\> 18 s, prothrombin activity \\\u003C 40%). (5) Platelet count \\\u003C 70×109\u002FL, or anticoagulant and\u002For antiplatelet drugs have not been discontinued for more than 1 week before ablation (except for prophylactic use of low-molecular-weight heparin before the operation). (6) Severe impairment of lung function, with maximum ventilation \\\u003C 40%. (7) Concurrent with other tumors and extensive metastasis, with an expected survival period of less than 3 months. (8) Poor general condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe insufficiency of vital organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term. (9) Eastern Cooperative Oncology Group (ECOG) performance status score \\> 2. (10) The lesion to be ablated has received radiotherapy within the past 6 months. (11) Presence of active hepatitis B, active hepatitis C, history of human immunodeficiency virus (HIV) infection (known positive for HIV 1\u002F2 antibodies), or other active infections that may affect the patient's treatment as judged by the investigator. (12) Accompanied by epilepsy, history of mental illness or cognitive impairment. (13) Pregnant or lactating women, and male or female patients planning to conceive or become pregnant during the trial. (14) Participation in any other clinical trial within 3 months before signing the informed consent form (except for non-interventional studies). (15) Other circumstances considered inappropriate for participation in this clinical trial by the investigator.",{"count":290,"type":21},10,[24],"The goal of this single-arm clinical trial is to evaluate the safety and efficacy of robotic bronchoscopy system (RBS)-assisted cryoablation in the treatment of primary lung cancer in adult patients (aged ≥18 years) with histologically confirmed non-resectable primary lung cancer, regardless of gender. The main questions it aims to answer are:\n\nDoes RBS-assisted cryoablation achieve a predefined target technical success rate for complete tumor ablation under imaging guidance? Is the incidence of severe procedure-related adverse events within an acceptable safety threshold ?\n\nParticipants will:\n\nProvide written informed consent for RBS-assisted cryoablation.\n\nUndergo pretreatment evaluations, including:\n\nMultimodal imaging (CT\u002FPET-CT) for tumor localization and staging. Pulmonary function tests and cardiopulmonary risk assessment. Receive RBS-guided cryoablation therapy under general anesthesia. Be monitored for intraoperative complications and postoperative adverse events for 72 hours.\n\nComplete follow-up assessments at 1, 3, 6, and 12 months post-procedure, including:\n\nContrast-enhanced CT scans to evaluate local tumor control. Documentation of symptom progression and quality-of-life metrics.",[294],"Lung Cancer Patients","2025-02-12",{"date":297,"type":35},"2025-02-18",{"date":299,"type":21},"2025-02-15",{"date":301,"type":21},"2025-12-31",{"name":41,"class":42},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":318,"locationsCount":4},"100580102","a-real-world-case-study-evaluating-the-efficacy-and-safety-of-rbs-cryobiopsy-100580102","NCT06832930","A Real-World Case Study Evaluating the Efficacy and Safety of RBS Cryobiopsy","A Real-World Case Study Evaluating the Efficacy and Safety of Bronchial Navigation Localization Device-Assisted Cryobiopsy","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Patients are eligible for inclusion if they meet all of the following criteria:\n\n  1. Age ≥18 years and ≤75 years, with no gender restrictions;\n  2. Presence of a peripheral lung lesion on chest CT\n  3. Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;\n  4. patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from this study:\n\n  1. Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \\\u003C60×10\\^9\u002FL), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;\n  2. Female patients who are breastfeeding, pregnant, or planning pregnancy;\n  3. Patients with electromagnetic active implantable medical devices;\n  4. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;\n  5. Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;\n  6. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.\n\n     Exclusion Criteria:",{"count":311,"type":21},200,[24],"The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are:\n\nDoes RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes.\n\nParticipants will:\n\nProvide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion.\n\nBe monitored for immediate and delayed complications .",[177],{"date":297,"type":35},{"date":299,"type":21},{"date":301,"type":21},{"name":41,"class":42},{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":334,"locationsCount":4},"100580103","the-efficacy-and-safety-of-robotic-bronchoscopy-system-assisted-stent-placement-in-patients-with-malignant-central-airway-stenosis-100580103","NCT06832943","The Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis","A Prospective Multicenter Single-Arm Trial Evaluating the Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis","Inclusion Criteria:\n\n* Patients are eligible only if they fulfill all of the following criteria:\n\n  1. Age ≥ 18 years, regardless of gender;\n  2. Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;\n  3. Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.\n\nPatients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients fulfilling any of the following criteria will be excluded from this study:\n\n  1. Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;\n  2. Apparent coagulation dysfunctions;\n  3. Pregnant or lactating women, or participants with a pregnancy plan during the study period;\n  4. Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;\n  5. Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;\n  6. Participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; Other circumstances that the investigator considers inappropriate for participation in this clinical trial.",{"count":20,"type":21},[24],"The primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.",[330],"Airway Stenosis",{"date":297,"type":35},{"date":299,"type":21},{"date":301,"type":21},{"name":41,"class":42},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":348,"leadSponsor":349,"locationsCount":4},"100580105","a-clinical-study-of-the-cryoablation-technique-for-peripheral-lung-malignancies-100580105","NCT06832969","A Clinical Study of the Cryoablation Technique for Peripheral Lung Malignancies","A Clinical Study on Verifying the Cryoablation Technique for Peripheral Lung Malignancies Under Bronchoscopy Guidance","Inclusion Criteria:\n\n* (1) Age ≥ 18 years, with no gender restrictions; (2) Diagnosed as having peripheral lung cancer, with the maximum diameter of the tumor being ≤ 3 cm and the number of tumors being ≤ 3; (3) The lesion intended for ablation is evaluated as feasible for bronchoscopy-guided cryoablation therapy; (4) The subject refuses or is deemed unsuitable for radiotherapy\u002Fchemotherapy, or has no response to previous radiotherapy\u002Fchemotherapy, or has disease progression after radiotherapy\u002Fchemotherapy; (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment and signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Diffuse lesions in both lungs where ablation therapy fails to improve the condition; (2) Examinations within one month prior to the operation reveal the presence of hilar lymph node metastasis or extrapulmonary metastasis (except for cases where extrapulmonary metastasis has been controlled through local treatment); (3) Existence of contraindications for bronchoscopy, or inability of the patient to tolerate or cooperate with bronchoscopy; (4) Severe bleeding tendencies or uncorrectable coagulation dysfunctions (prothrombin time \\> 18 seconds, prothrombin activity \\\u003C 40%); (5) Platelet count \\\u003C 70×109\u002FL, or discontinuation of anticoagulant and\u002For antiplatelet drugs less than one week before ablation (except for the prophylactic use of low-molecular-weight heparin before the operation); (6) Severe impairment of lung function with a maximum ventilation volume \\\u003C 40%; (7) Concurrent presence of other tumors with extensive metastasis and an expected survival period of less than 3 months; (8) Poor overall condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe dysfunction of important organs, severe anemia and short-term uncorrectable nutritional and metabolic disorders; (9) Eastern Cooperative Oncology Group (ECOG) performance status score \\> 2; (10) The lesion to be ablated has received radiotherapy within the past 6 months; (11) Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection history (known positive for HIV1\u002F2 antibodies), or other active infections that are judged by the researcher to potentially affect the patient's treatment; (12) Accompanied by epilepsy, history of mental illness or cognitive impairment; (13) Pregnant or lactating women, as well as male or female patients who plan to have children or become pregnant during the trial; (14) Participation in any other clinical trials within 3 months before signing the informed consent (excluding non-interventional studies); (15) Other circumstances deemed by the researcher as inappropriate for participation in this clinical trial.",{"count":290,"type":21},[24],"To assess the safety and effectiveness of bronchoscopy-guided cryoablation with cold verification for peripheral lung malignancies.",[294],{"date":297,"type":35},{"date":299,"type":21},{"date":301,"type":21},{"name":41,"class":42},{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":74},"100563226","feasibility-and-safety-of-remote-robotic-bronchoscopy-system-in-diagnosis-of-peripheral-pulmonary-lesions-a-multicenter-randomized-controlled-proof-of-concept-trial-100563226","NCT06613412","Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial","Inclusion Criteria:\n\nPatients are eligible for inclusion if they meet all of the following criteria:\n\nAge ≥18 years and ≤75 years, with no gender restrictions; Presence of a peripheral lung lesion on chest CT \\[Peripheral lung is defined as a nodule located in the fourth-order or higher airway (with the carina defined as order 0, the left and right main bronchi defined as order 1, lobar bronchi as order 2, segmental bronchi as order 3, and subsegmental bronchi as order 4)\\] in patients who require biopsy \\[2. The population requiring biopsy refers to individuals identified with an occupational lung lesion\u002Fnodule (including solid nodules, part-solid nodules, and ground-glass nodules) during clinical trial screening or with risk factors, and who, after comprehensive assessment by a clinician of the patient's clinical information, imaging, tumor markers, and functional imaging, are highly suspected of having cancerous nodules. Bronchoscopy biopsy is planned to further clarify the diagnosis and to guide staging treatment based on pathological results.\\]; Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure; Patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.\n\n\\-\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from this study:\n\n1.Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \\\u003C60×10\\^9\u002FL), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion; 2.Female patients who are breastfeeding, pregnant, or planning pregnancy; 3.Patients with electromagnetic active implantable medical devices; 4.Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history; 5.Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days; 6.Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.\n\n\\-",{"count":290,"type":21},[24],"Robotic bronchoscopy represents the latest localization technology for peripheral pulmonary nodules, enabling precise and stable manipulation, thereby enhancing the diagnostic yield of peripheral lung pathologies. Its safety and feasibility have been internationally validated, with indications that it can significantly improve the overall diagnostic rate of biopsies for peripheral lung lesions. Nonetheless, the disparity in interventional auxiliary equipment and the level of technical operation is the primary cause for the significant variation in diagnostic rates of peripheral lung lesions across different regions, particularly in remote or underdeveloped areas. The advancement of 5G network technology has propelled the development of telemedicine, enabling remote diagnostics, surgeries, and real-time multi-party collaboration, which is expected to elevate the medical standards in remote areas, improve the diagnostic rate of peripheral lung lesions, and achieve homogenization of medical services. In summary, the integration of 5G with bronchoscopy is anticipated to bring breakthroughs in the diagnosis and treatment of peripheral lung pathologies.\n\nResearch Objective:\n\nThe primary objective of this clinical trial is to evaluate the safety and efficacy of the remote application of bronchoscopy systems and catheters for the localization and sampling of peripheral pulmonary nodules, under the premise of ensuring the safety of the subjects and the scientific integrity of the clinical trial, with the aid of 5G network.\n\nResearch Method:\n\nThe study is a prospective, multicenter, single-arm clinical trial with a target value design, intending to include 10 cases of individuals with peripheral pulmonary nodules who are willing to undergo intra-airway examination and sampling operations using remote bronchial navigation localization devices assisted by the 5G communication network. The safety and efficacy of the bronchial navigation localization devices and catheters for the localization and sampling of peripheral pulmonary nodules, developed by Changzhou Langhe Medical Devices Co., Ltd. (hereinafter referred to as \"Langhe Medical\"), will be assessed.\n\nAnalysis:\n\nStatistical data analysis will be performed using SAS software version 9.4 or higher.",[360],"Pulmonary Nodule",[362,363,364],"peripheral pulmonary lesions","remote bronchoscopy","robotic bronchoscopy system","2024-11-20",{"date":367,"type":35},"2024-11-22",{"date":369,"type":35},"2024-09-15",{"date":299,"type":21},{"name":41,"class":42},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":4},"100551591","phase-2-sacituzumab-govitecan-combined-with-head-radiotherapy-for-her2-negative-breast-cancer-brain-metastases-100551591","NCT06462079","Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases","A Phase II Clinical Study of Sacituzumab Govitecan Combined With Head Radiotherapy for the Treatment of Brain Metastases From Her2-negative Breast Cancer","Inclusion Criteria:\n\n1. Have a definitive pathologic diagnosis of breast cancer with subtype Her2- (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);\n2. Have a measurable intracranial lesion;\n3. Age ≥ 18 years;\n\nExclusion Criteria:\n\n1. Patients with cerebrospinal membrane metastases;\n2. Patients with acute\u002Fsubacute hemorrhagic metastasis;\n3. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10\\^9\u002FL, PLT ≤ 90 x 10\\^9\u002FL, Hb ≤ 90g\u002FL; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;\n4. Presence of serious and\u002For uncontrolled comorbidities that may affect participation: 1) allergy to study medications or adjuvant materials; 2) history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases; 3) serious concomitant illnesses;\n5. Pregnant and lactating female patients; female patients of childbearing age who are unwilling to use effective contraception during the trial period;\n6. Patients who are unable to complete enhanced contrast MRI;\n7. Patients who have been treated with Sacituzumab Govitecan and are resistant to the drug;\n8. Any other condition that, in the opinion of the investigator, makes the patient ineligible for study participation.",{"count":380,"type":21},43,[54],"The incidence of brain metastasis of Her2-negative breast cancer is high, which seriously affects the prognosis of patients.The treatment of brain metastasis of Her2-negative breast cancer is still tricky. The local efficacy of head radiotherapy for breast cancer brain metastases is remarkable, and systemic tumor progression in patients with brain metastases is the main reason for treatment failure. Sacituzumab Govitecan is the only Trop-2 antibody-coupled drug (ADC) approved for the treatment of unresectable locally advanced or metastatic Her2-negative breast cancer. However, the objective remission rate of Sacituzumab Govitecan for intracranial metastatic lesions has not been satisfactory. This study is an open, uncontrolled phase II clinical study to observe the efficacy and safety of Sacituzumab Govitecan combined with intracranial radiotherapy in the treatment of patients with brain metastases from Her2-negative breast cancer, in order to find a more effective treatment method.",[384],"Brain Metastasis",[111,112,386,113,387],"Brain metastasis","Radiation therapy","2024-06-12",{"date":390,"type":35},"2024-06-17",{"date":392,"type":21},"2024-06-15",{"date":394,"type":21},"2027-07-15",{"name":41,"class":42},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":403,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":74},"100333833","peri-operative-nutrition-in-infants-with-congenital-heart-disease-100333833","NCT03626480","Peri-operative Nutrition in Infants With Congenital Heart Disease","A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease","Inclusion Criteria:\n\n* All children in the multi-center who met the following criteria:\n\n  1. under 1 years old (including 1 years old);\n  2. diagnosed as congenital heart disease and planed to surgery;\n  3. parents have basic literacy skills, communication and accessibility\n  4. parents are informed consent and volunteered to participate with the approval of the hospital ethics committee,\n\nExclusion Criteria:\n\n* (1) suspected as chromosomal disease; (2) diagnosis of genetic metabolic diseases; (3) anyway affecting oral feeding (eg. Cleft palate) (4) previous gastrointestinal surgery (eg. Postoperative gastrointestinal fistula)","1 Day","12 Months",{"count":406,"type":21},20000,"The purpose of our multi-center cohort study is to build a large platform to follow up the peri-operative nutrition of children with congenital heart disease. And data will be collected pre and 1, 3, 6, 12 months post surgery including physical, laboratory, imaging examination and questionnaire. The primary outcome is nutrition status (measured as WAZ, WHZ and HAZ) and secondary outcomes were the biochemical index and quality of life.",[409],"Congenital Heart Disease",[411,412,413],"Surgery","Nutritional outcome","Infants","2020-02-07",{"date":416,"type":35},"2020-02-11",{"date":418,"type":35},"2018-07-09",{"date":420,"type":21},"2028-09-01",{"name":41,"class":42},""]