[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"margin-assessment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:margin-assessment":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,70,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100604414","phase-2-intraoperative-molecular-imaging-using-icg-for-head-and-neck-tumors-100604414",false,"NCT07149207","Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors","Inclusion Criteria:\n\n1. Adult subjects at least 18 years of age.\n2. Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.\n3. Good operative candidate as determined by the treating physician and\u002For multidisciplinary team.\n4. Subject capable of giving informed consent and participating in the process of consent.\n5. A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and\u002For implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.\n2. A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:\n\n   1. they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or\n   2. they have had a hysterectomy.\n3. Known allergy to iodides or shellfish.\n4. Inadequate organ function at time of screening as defined below:\n\n   a. Hepatic\n   1. Total bilirubin \\>2 x IULN. Participants with a history of Gilbert's disease must have total bilirubin \\\u003C3mg\u002FdL.\n   2. AST (SGOT) and ALT (SPGT) \\>3 x IULN.\n5. Currently incarcerated individuals","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.",[25,26],"Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Margin Assessment",[28,29,30,31],"Cancer","surgical margins","head and neck cancer","mucosal squamous cell cancer","RECRUITING","2026-05-11",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":36},"2026-05-04",{"date":40,"type":19},"2029-04-07",{"name":42,"class":43},"Medical University of South Carolina","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100628240","spectral-cancer-tissue-recognition---i-100628240","NCT07459062","Spectral Cancer Tissue Recognition - I","Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.","SPCTR-I","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis breast cancer for which surgical procedure is needed\n* Planned for breast conserving surgery\n\nExclusion Criteria:\n\n* Person that undergoes breast amputation without confirmed cancer diagnosis",{"count":54,"type":19},100,"OBSERVATIONAL","This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able to achieve the following outcomes with classifying tissues:\n\n* Sensitivity (percentage of classified positive margins of actual positive margins): ≥ 96% CI 95.5-97.5%\n* Specificity (percentage of classified free margins of actual free margins): 96% CI 95.5-97.5%\n* Accuracy (total correctly classified margins): ≥ 96% CI 95.5-97.5%\n* Negative predictive value (amount of true negative - free margins - among the classified negative margins): ≥ 95% CI 94.5-96.5%",[26,58],"Breast Cancer","2026-03-06",{"date":61,"type":36},"2026-03-09",{"date":63,"type":36},"2026-01-12",{"date":65,"type":19},"2026-08-01",{"name":67,"class":68},"SPCTR","INDUSTRY",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":16,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100594366","epcam-targeted-surface-enhanced-raman-spectroscopy-nanotags-for-rapid-evaluation-of-surgical-margins-and-sentinel-lymph-node-metastasis-status-in-breast-cancers-100594366","NCT07018505","EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast cancer to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study","FEMALE","75 Years",{"count":79,"type":19},40,"For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable \"sandwich\" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.",[82,83,84,26],"Sentinel Lymph Node","Breast Cancers","Metastases",[82,86,87,88,89],"Surface Enhanced Raman Spectroscopy","EpCAM","Breast cancers","Surgical margin","NOT_YET_RECRUITING","2025-06-04",{"date":93,"type":36},"2025-06-12",{"date":95,"type":19},"2025-06-15",{"date":97,"type":19},"2026-07-01",{"name":99,"class":43},"Yunnan Cancer Hospital",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":76,"minAge":16,"maxAge":77,"enrollmentInfo":107,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":44},"100570893","tumor-targeted-nir-ii-fluorescent-molecular-probes-for-the-identification-of-breast-cancer-tissue-and-sln-metastatic-status-100570893","NCT06713161","Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status","NIR-II","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study",{"count":79,"type":19},"Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.",[58,82,84,26],[105,58,82,111,84],"Surgical Navigation","2024-11-27",{"date":114,"type":36},"2024-12-03",{"date":116,"type":36},"2024-09-01",{"date":118,"type":19},"2025-12-25",{"name":99,"class":43}]