[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Copernicus Memorial Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":169},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,84,114,140],{"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":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100602735","comparison-of-clinical-outcomes-complications-rate-and-treatment-costs-of-mini-tlif-and-midlif-in-the-treatment-of-discogenic-low-back-pain-100602735",false,"NCT07127380","Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain","MID-MIS Trail Protocol - Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain","MID-MIS","Inclusion Criteria:\n\n* Discogenic lower lumbar-sacral pain lasting longer than one year\n* Failure of conservative treatment, including rehabilitation and pain management\n* Lumbar discopathy qualified for interbody fusion and pedicle screw stabilization\n* Informed consent of the patient for the study and proposed treatment\n\nExclusion Criteria:\n\n* Contraindications to surgery under general anesthesia\n* Age \\\u003C 18 years\n* Pregnancy, breastfeeding\n* Lack of informed consent to participate in the study\n* Lumbar-sac discopathy requiring surgical treatment at more than two levels\n* Spinal deformities: adult idiopathic scoliosis, degenerative scoliosis, deformity due to spinal malignancy, inflammatory spinal disease, post-traumatic, or associated with congenital anomalies\n* Lower lumbar-sacral pain syndrome, which, in the investigator's opinion, has an etiology other than degenerative spine disease (e.g., cancer-related pain, ankylosing spondylitis)\n* Spinal oncology disease\n* True and degenerative spondylolisthesis\n* Contraindications to performing MRI of the lumbar-sacral spine","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background\n\nDegenerative disc disease (DDD) is the leading cause of lower back pain and disability, which prevalence increasing with age. When conservative treatment fails, surgical methods of spinal fusion are employed. Minimally invasive techniques, including minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), have well-documented advantages over traditional open transforaminal interbody fusion (open-TLIF). However, data comparing these two minimally invasive methods in treating DDD are minimal and sometimes contradictory. I am running a few minutes late; my previous meeting is running over.\n\nMethods This is a prospective, randomized, partially blinded, two-arm trial aiming to compare the outcomes, complications, and treatment costs of MIS-TLIF and MIDLIF in patients with discogenic low back pain. A total of 100 adult patients with lumbosacral spine pain and radicular symptoms, unresponsive to conservative treatment for over one year, will be enrolled. Patients will be randomized (1:1) into two arms: MIS-TLIF (control, n=50) and MIDLIF (intervention, n=50), with a 12-month follow-up. Inclusion criteria include age ≥18 years and discopathy at one or two levels requiring interbody stabilization. Exclusion criteria include multilevel pathology, spinal deformities, and pain causes other than degenerative disease. Primary endpoints assess pain (VAS, NRS scales), disability (COMI, ODI questionnaires), and quality of life (EQ-5D-5L questionnaire) at 1, 3, 6, and 12 months post-surgery. Secondary endpoints include complication rates (nerve root damage, infections), costs (hospitalization, implants), length of hospital stay, procedure duration, blood loss, morphometric parameters (intervertebral space height), and adjacent segment disease based on imaging studies (MRI, CT, X-ray). Data analysis uses parametric\u002Fnon-parametric tests (e.g., t-test, Mann-Whitney) in the R software. The trial adheres to the Helsinki Declaration, with ethics approval (no. 112\u002F2024).\n\nDiscussion Data on the comparison of MIDLIF and MIS-TLIF in treating DDD are minimal and inconsistent. Some reports have advantaged MIDLIF in shorter operative time, decreased intraoperative blood loss, and reduced hospital stays, while others favor MIS-TLIF. This trial addresses these gaps by providing high-quality evidence on clinical superiority, cost-effectiveness, and long-term outcomes compering MIDLIF and MIS-TLIF. There is a high need for a high-quality, prospective study to examine this problem.",[27,28,29,30],"Lower Back Pain Chronic","Lumbar Degenerative Disease","Lumbar Disc Degeneration","Degenerative Disc Disease(DDD)",[32,33,29,34,35,36,37,38,39,40,41],"Degenerative Disc Disease","Lower Back Pain","Discogenic Pain","MIS-TLIF","MIDLIF","mini-TLIF","Minimally Invasive Transforaminal Lumbar Interbody Fusion","Midline Lumbar Interbody Fusion","Spinal stabilization","Spinal fusion","RECRUITING","2026-04-14",{"date":45,"type":46},"2026-04-15","ACTUAL",{"date":48,"type":46},"2025-01-19",{"date":50,"type":21},"2028-01-31",{"name":52,"class":53},"Copernicus Memorial Hospital","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":54},"100551895","application-of-fet-pet-in-fusion-with-mri-in-the-treatment-of-glioblastoma-multiforme-tyr-glio-100551895","NCT06466031","Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO]","Application of FET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study","TYR-GLIO","Inclusion Criteria:\n\n* Single macroscopic tumor focus with the appearance of glioblastoma multiforme on MRI with contrast - contrast-enhancing lesion, completely or with central necrosis, with surrounding edema.\n* No history of cancer in other organs. No suspicious lesions on X-ray of the chest and abdomen (CT with contrast).\n* No clinical suspicion of brain abscess - no meningeal symptoms, signs of neuroinfection, fever, elevated inflammatory parameters.\n* Primary tumor, without neurosurgical, radiotherapy or oncology intervention. Prior tumor biopsy is allowed.\n* Tumor eligible for surgical treatment - craniotomy and tumor resection.\n* Age ≥ 18 years but \\\u003C 70 years old.\n* Quality of life assessment: KPS ≥ 70.\n* Informed patient consent to the study and proposed treatment.\n* No allergy to contrast agents used in PET and MRI.\n* No medical contraindications to neurosurgery - craniotomy and resection.\n\nExclusion Criteria:\n\n* Multifocal brain tumor.\n* Recurrence of glioblastoma multiforme.\n* Clinical or radiological suspicion of brain metastasis or brain abscess.\n* Postoperative histopathological diagnosis other than WHO grade IV glioblastoma.\n* Medical contraindications to any surgery under general anesthesia.\n* Pregnancy, breastfeeding.\n* Known allergy to gadolinium contrast or radiopharmaceutical tracing agent.","70 Years",{"count":65,"type":21},189,[24],"Glioblastoma multiforme (GBM WHO IV) is the most common and aggressive primary brain tumor in adults, carrying a poor prognosis with a median survival of 12-16 months. The annual incidence is approximately 5 per 100,000 (roughly 600 cases annually in Poland), predominantly affecting individuals in their prime productive years. The standard of care consists of maximal safe resection followed by the Stupp protocol (60 Gy fractionated radiotherapy and temozolomide chemotherapy).\n\nRoutine surgical management relies on contrast-enhanced MRI. Gross total resection (GTR) is defined as the complete removal of the contrast-enhancing lesion. Although GTR improves progression-free survival (PFS) and overall survival (OS), local recurrence at the operative site occurs in up to 51% of patients within a year. This rapid regrowth is driven by glioblastoma stem cells infiltrating the surrounding non-enhancing brain tissue. Consequently, standard contrast-enhanced MRI lacks the sensitivity required to define true tumor boundaries for optimal patient outcomes.\n\nTo overcome this, positron emission tomography (PET-CT) using amino acid tracers like 18F-fluoroethyl-L-tyrosine (18F-FET) offers a promising alternative. Unlike 18-FDG, which is obscured by physiologically high glucose uptake in healthy brain tissue, 18F-FET provides high specificity and sensitivity for glial tumors. Crucially, studies show that MRI contrast enhancement overlaps with only 58% of the hypermetabolic area identified by 18F-FET. While \"supramarginal\" resections based on FLAIR MRI abnormalities (assumed to contain infiltrating stem cells) improve PFS by roughly 2 months, the FLAIR sequence cannot definitively distinguish active tumor infiltration from standard peritumoral edema.\n\nThis proposed experiment carries significant innovative value: it aims to use the fusion of 18F-FET PET and contrast-enhanced MRI to precisely guide both primary surgical resection and postoperative radiotherapy. By redefining the primary target volume to include the area of true biological tumor activity rather than just the MRI-enhancing mass (incorporating it into GTV, CTV, and PTV planning), the procedure directly targets residual glioblastoma stem cells. While PET has been evaluated for radiotherapy planning in recurrent GBM, high-quality data regarding its use for primary surgical planning is lacking. This study aims to fill that crucial gap in the literature.",[69],"Glioblastoma Multiforme",[69,71,72,73,74,75,76],"Methionine","Positron-Emission Tomography","Brain neoplasms","Progression-free survival","Dose Fractionation, Radiation","Post-surgical radiotherapy",{"date":78,"type":46},"2026-04-17",{"date":80,"type":46},"2025-12-08",{"date":82,"type":21},"2032-08-31",{"name":52,"class":53},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100556586","ln-rads-recist-11-and-node-rads-classification-in-the-assessment-of-lymph-nodes-100556586","NCT06527027","LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes","Comparison of the LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes in MRI and CT in Relation to Histopathological Results - a Prospective, Randomised Study","Inclusion Criteria:\n\n* diagnosed or suspected cancer,\n* planned lymph node biopsy or lymphadenectomy,\n* planned or performed CT\u002FMRI covering an area of the body with lymph nodes, - verified histopathologically or cytologically,\n* informed consent to participate in the study.\n\nExclusion Criteria:\n\n* non-diagnostic CT\u002FMRI images of lymph nodes due to reasons such as movement artifacts, artifacts from metal elements and any other factors that do not allow for proper assessment of the nodes,\n* inconclusive histopathological or cytological results, which do not allow the nodes to be classified into one of two groups - benign or malignant.",{"count":92,"type":21},1000,[24],"The project aims to evaluate the value of the new LN-RADS scales for lymph node classification in CT and MR and to compare this method with two other methods RECIST 1.1 and Node-RADS.\n\nThe main tested system in the study is LN-RADS, the comparators are RECIST 1.1 and Node-RADS criteria.\n\nLymph nodes are a key diagnostic and therapeutic element in oncology. Despite the technological progress, the detection of neoplastic changes in the lymph nodes is of low effectiveness, which results from the imperfection of the criteria used. Currently, the most widely used criterion is the RECIST 1.1 guideline developed in the 1990s, according to which the lymph node dimension in the short axis with a cut-off point of 10 mm is decisive. Lymph nodes smaller than 10 mm across are considered normal. It is a criterion with a high error rate, both due to the false-negative diagnoses (with small metastases below 10 mm) and false-positive diagnoses (in the case of inflammatory lymphadenopathy).\n\nA particular disadvantageous situation is when the metastatic nodes and their transverse dimension is less than 10 mm, because they are treated as healthy nodes and the degree of the disease advancement is underestimated. As a result, the patient is not treated properly - no complete lymphadenectomy, no radiotherapy to the area of these nodes or insufficient systemic treatment. In all cases, underestimating the stage of the neoplastic diseases increases the risk of the recurrence.\n\nLN-RADS accounts small metastases in nodes about 3 mm in size, thus about 20% more metastatic nodes may be detected compared to RECIST 1.1 method. This means that currently, according to RECIST 1.1 rules, approx. 20% of patients have missed nodal metastases and consequently receive insufficient treatment resulting in relapse. Previous studies have shown that RECIST 1.1 shows a high level of underestimation of metastatic nodes. The Node-RADS system, as the second comparator next to RECIT 1.1, is a fairly new system moving towards the structural assessment of lymph nodes, but proposed arbitrarily, without hard evidence for its effectiveness. Despite the publication of the Node-RADS system in a medical journal, it is not validated. The Node-RADS has numerous limitations and weaknesses that reduce its value.",[96,97],"Lymph Node Neoplasm","Lymph Node Metastasis",[99,100,101,102,103,104],"Lymph Nodes","Lymph Node Excision","Tomography, X-ray computed","Lymphadenopathy","Recurrence","Magnetic Resonance Imaging","2025-12-21",{"date":107,"type":46},"2025-12-30",{"date":109,"type":46},"2023-12-01",{"date":111,"type":21},"2028-12-31",{"name":52,"class":53},6,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":139,"locationsCount":5},"100538616","carbon-fiber-transpedicular-screws-in-treatment-of-spinal-metastatic-disease-100538616","NCT06293157","Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease","Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial","CarboMetaspine","Inclusion Criteria:\n\n* Metastatic spinal disease,\n* ECOG quality of life of 0-2,\n* Eligibility for SBRT treatment,\n* Expected survival time \\>3 months,\n* Signed informed consent to participate in the study,\n* Sufficient organ capacity allowing to survive the perioperative period.\n\nExclusion Criteria:\n\n* Primary tumor of the spine,\n* Age \\\u003C18 years old,\n* Expected survival time \\\u003C3 months,\n* Eligibility for palliative radiotherapy,\n* No informed consent to participate in the study,\n* Pregnancy or breastfeeding,\n* The advancement of the disease preventing the technical use of implants.",{"count":123,"type":21},226,[24],"Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.\n\nStudy plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.\n\nStudy population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.\n\nAssumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.",[127,128],"Metastatic Spinal Cord Compression","Metastasis Spine",[130,131,132,133],"metastatic spinal disease","stereotactic body radiotherapy","spinal cord compression","carbon fiber reinforced implants",{"date":135,"type":46},"2025-12-16",{"date":109,"type":46},{"date":138,"type":21},"2033-12-31",{"name":52,"class":53},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100556743","radiotherapy-strategies-for-use-in-combined-treatment-of-small-cell-lung-cancer-100556743","NCT06529081","Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer","Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment","Inclusion Criteria:\n\n* Histopathological confirmation of small cell lung cancer based on histological or cytological examination.\n* Primary clinical stage: Extensive stage of the disease according to VASLG classification or stage IV according to TNM classification.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 prior to randomization.\n* Partial response (PR) or stable disease (SD) to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging (positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] or CT or magnetic resonance imaging \\[MRI\\]).\n* Ability to undergo radiotherapy at a total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and a total dose of 24 Gy administered in single fractions every 2-3 days of 8 Gy to the metastatic lesions.\n* Clinical control of brain metastases (prior whole-brain irradiation at any stage is acceptable before study entry).\n* Measurable residual disease after chemioimmunotherapy (according to RECIST 1.1 solid tumor response assessment criteria) or in case of CR\u002FPR presence of tumor lesions not classified as measurable.\n* Volume and number (up to 10) of metastatic lesions allowing for radiotherapy in doses according to the study protocol.\n* Absence of clinically significant and uncontrolled co-morbidities with pharmacological treatment.\n* Absence of active autoimmune diseases except for diabetes, hypothyroidism, psoriasis, eczema, lichen planus, and vitiligo.\n* Adequate hematopoietic function allowing treatment with atezolizumab or durvalumab, according to the current SmPC (Summary of Product Characteristics).\n* Renal and hepatic function allowing treatment according to the current SmPC for atezolizumab or durvalumab.\n\nExclusion Criteria:\n\n* Age under 18 years old.\n* Premenopausal women who do not accept the need for effective contraception during radiotherapy and\u002For chemotherapy\u002Fimmunotherapy.\n* Individuals excluded from participation in a medical experiment based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.\n* Coexistence of other uncontrolled malignant neoplasms.\n* Contraindications to the use of atezolizumab or durvalumab as specified in the SmPC.\n* Grade 2 or greater CTCAE v.5 pneumonitis secondary to immunotherapy.\n* Participation in another clinical trial during the study.\n* Prior chest radiotherapy that precludes safe administration of radiotherapy according to the study protocol. Prior palliative radiotherapy to metastatic sites is acceptable before study entry if clinically indicated as determined by the physician.\n* Contraindications to radiotherapy according to the approved protocol.",{"count":148,"type":21},165,[24],"The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy, focusing on residual changes following chemo-immunotherapy (during immunotherapy) and its effect on progression-free survival.\n\nThis research experiment will be conducted as a randomized multi-center study, comprising the following treatment arms:\n\n* Arm I: Continuation of standard of care - PDL1\u002FPD1 immunotherapy (durvalumab or atezolozumab) after chemo-immunotherapy based on platinum compounds;\n* Arm II: Standard of care, followed by consolidating radiotherapy of the chest area and possibly metastases (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each);\n* Arm III: Standard of care, followed by consolidating radiotherapy in the radical\u002Fablative doses (total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area, and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions) of the chest area and all metastatic lesions.\n\nAdditionally, as part of routine weekly blood collections, an extra volume of 10 ml of blood will be collected. This additional blood sample will be obtained before starting radiotherapy, during each week of radiotherapy (maximum three collections), and at the time of disease progression (one collection), resulting in a total of five extra samples. The collected blood will be prepared, stored and used for circulating tumor DNA (ctDNA) testing, according to the protocol. The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy.",[152],"Small Cell Lung Carcinoma",[152,154,155,156,157,158,159],"Extensive Disease","Chemo-immunotherapy","Radiotherapy","Durvalumab","Atezolizumab","Immunotherapy","2025-08-22",{"date":162,"type":46},"2025-08-28",{"date":164,"type":46},"2024-04-01",{"date":166,"type":21},"2029-12-31",{"name":52,"class":53},2,""]