[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fap\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fap":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,64,89,123,152,180,203,223,254,292,322,341],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":42,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886",false,"NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.","ALL","18 Years",{"count":19,"type":20},595,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","Metastatic Castration-resistant Prostate Cancer","FAP","Endometrial Carcinoma","Prostate Cancer","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[27,29,30,31,43,44,45,34,46,47,48,49,50],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","RECRUITING","2026-05-26",{"date":54,"type":55},"2026-05-28","ACTUAL",{"date":57,"type":55},"2023-05-23",{"date":59,"type":20},"2027-08-31",{"name":61,"class":62},"Parabilis Medicines, Inc.","INDUSTRY",33,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100565302","phase-1-a-study-to-evaluate-the-safety-and-preliminary-signs-of-efficacy-of-177lulu-oncofap-23-alone-or-in-combination-with-l19-il2-as-a-treatment-of-metastatic-fap-positive-solid-tumors-100565302","NCT06640413","A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors","A Phase I Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors","TheraTri","Inclusion Criteria:\n\n1. Patients with advanced\u002Fmetastatic solid tumors, who have progressed on available standard treatments.\n2. Patients with FAP-positive tumors as evaluated by \\[68Ga\\]Ga-OncoFAP-DOTAGA-PET\u002FCT imaging.\n3. Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.\n4. Male or non-pregnant and non-breast feeding female, age 18 or more.\n5. Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Survival expectation of more than 12 weeks.\n8. Ability to undergo standard imaging.\n9. Documented negative test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV). For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBsAg-Ab with no history of vaccination and\u002For anti-HBcAg-Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n10. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.\n11. Female patients: negative blood pregnancy test at Screening for women of childbearing potential (WOCBP)\\*. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical ; issued by the Head of Medicine Agencies; Clinical Trial Facilitation Group (www.hma.eu\u002Fctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.\n12. Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.\n13. A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and has given consent to participate in the study.\n14. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\n    * Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).\n\nExclusion Criteria:\n\n1. Any cancer therapy within 4 weeks of study entry.\n2. Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.\n3. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.\n4. White blood cell count (WBC) minor than 2.5 x 109\u002FL, absolute neutrophil count (ANC) minor than 1.5 x 109\u002FL, platelets minor than 100 x 109\u002FL or hemoglobin (Hb) minor than 9.0 g\u002Fdl,\n5. Chronically impaired renal function as expressed by creatinine clearance minor than 60 mL\u002Fmin or serum creatinine major than 1.5 ULN.\n6. Inadequate liver function (Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 x Upper Limit of Normal (ULN), or Alkaline Phosphatase (ALP) or Gamma Glutamyl Transferase (GGT) ≥ 2.5 x ULN, or total bilirubin ≥ 1.5 x ULN). For patients with metastatic lesions in the liver ALT, AST, GGT or ALP ≥ 5 x ULN.\n7. Presence of cirrhosis or active hepatitis.\n8. Patients with Central Nervous System (CNS) metastases.\n9. History within the last year of cerebrovascular disease and\u002For acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n10. Heart insufficiency (major Grade II, New York Heart Association (NYHA) criteria).\n11. Clinically significant cardiac arrhythmias or requiring permanent medication.\n12. Abnormal Left Ventricular Ejection Fraction (LVEF) or any other abnormalities observed during baseline Electrocardiogram (ECG) and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT\u002FQTc prolongation would be excluded. In particular: - patients with a marked prolongation of QT\u002FQTc interval (e.g., repeated demonstration of QTc major than 480 milliseconds using Fredricia's QT correction formula) are excluded; - patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded; - patients who require the use of concomitant medications that prolong the QT\u002FQTc interval are excluded.\n13. Cardioversion in the previous 12 months\n14. Uncontrolled hypertension as defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg at 3 consecutive measurements performed within one week. Note: if the first blood pressure measurement is below threshold for systolic or diastolic blood pressure, it is not required to repeat the measurement.\n15. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).\n16. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.\n17. Pregnancy or lactation or unwillingness to use adequate method of birth control.\n18. Any severe concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.\n19. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 4 weeks of administration of the study drug.\n20. Serious, non-healing wound, ulcer or bone fracture.\n21. Known history of allergy to an excipient in study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies\n22. Systemic chronic steroid therapy (major than 10 mg\u002Fday prednisone or equivalent) or any other immunosuppressive therapy within 14 days prior to study treatment start. Topical, inhaled, nasal and ophthalmic steroids are allowed.\n23. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n24. Concurrent or previous malignancies (other than the indication for this trial), unless a complete remission without further recurrence was achieved at least 2 years prior to study treatment start.\n25. Growth factors or immunomodulatory agents within 7 days prior to study treatment start.\n26. Deep vein thrombosis, pulmonary embolism, or other acute vascular events within 6 months.",{"count":73,"type":20},56,[23],"The aim of this study is to assess the safety of \\[177Lu\\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced\u002Fmetastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).",[37],[78],"Patients with advanced\u002Fmetastatic FAP-positive tumors","2026-01-13",{"date":81,"type":55},"2026-01-14",{"date":83,"type":55},"2025-10-31",{"date":85,"type":20},"2028-12-31",{"name":87,"class":62},"Philogen S.p.A.",4,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":110,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100608251","duodenal-polyposis-classification-in-fap-100608251","NCT07199127","Duodenal Polyposis Classification in FAP","Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis","DRACO","Inclusion Criteria:\n\n* Confirmed germline diagnosis of FAP, as defined by genetic testing\n* Two or more upper gastrointestinal endoscopies\n* Complete documentation of all Spigelman classification variables at each endoscopic evaluation\n\nExclusion Criteria:\n\n* Histological grading of duodenal polyps incomplete\n* Follow-up data were unavailable\n* Duodenal surgery before study baseline endoscopy",{"count":98,"type":20},300,"OBSERVATIONAL","Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.",[102,103,104,105,106,37,107,108,109],"Duodenum Cancer","Familial Adenomatous Polyposis","Duodenal Polyposis","Ampulla of Vater Adenoma","FAP Gene Mutation","Duodenal Neoplasms","Duodenal Adenoma","Ampulla of Vater Cancer",[111,104],"Spigelman","2025-09-22",{"date":114,"type":55},"2025-09-30",{"date":116,"type":55},"2018-02-02",{"date":118,"type":20},"2030-01-15",{"name":120,"class":121},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",2,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100560552","investigation-of--hydroxybutyrate-supplementation-as-chemoprevention-in-familial-adenomatous-polyposis-100560552","NCT06578637","Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis","BHB-FAP","Part A\n\nInclusion Criteria:\n\n1. Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts\n2. Must have an extensive colonic resection with either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA)\n3. Can provide informed consent\n\nExclusion Criteria:\n\n1. Subject is pregnant, a prisoner, or is under 18 years of age\n2. Prior total proctocolectomy with end ileostomy\n3. History of inflammatory bowel disease\n4. History of diabetes mellitus and are currently on medical diabetes therapy\n5. History of chronic kidney disease with an eGFR \\< 60 mL\u002Fmin\u002F1.73m2\n6. Cancer diagnosis where the subject is receiving active therapy\n7. Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment\n\nPart B\n\nInclusion Criteria:\n\n1. Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts.\n2. Willing to undergo a colonoscopy or sigmoidoscopy, which may be part of the patient's routine standard care.\n3. Able to have a concurrent upper endoscopy performed with the colonoscopy\u002Fsigmoidoscopy. This upper endoscopy may be part of the patient's routine standard care.\n4. Have at least two colorectal polyps at enrollment (which can be present anywhere in the colon including the rectal cuff, or in the J-pouch \\[if applicable\\]).\n5. Can provide informed consent.\n\nExclusion Criteria:\n\n1. Subject is pregnant, a prisoner, or is under 18 years of age\n2. Patient is not able to undergo colonoscopy\u002Fsigmoidoscopy or upper endoscopy\n3. Prior total proctocolectomy with end ileostomy\n4. History of inflammatory bowel disease\n5. History of diabetes mellitus and are currently on medical diabetes therapy\n6. History of chronic kidney disease with an eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2\n7. Cancer diagnosis where the subject is receiving active therapy\n8. Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment\n9. Regular use of any FAP-related chemopreventive agent in the 6 weeks prior to enrollment including aspirin (\\> 81mg daily), NSAIDs, BHB supplementation, or any other medication deemed a chemopreventive agent by the study investigators\n10. Any colonic or small intestinal polyp observed endoscopically that is \\> 1 cm in size and is not removed (excluding ampullary adenomas)",{"count":131,"type":20},20,[133],"NA","The aim of this study is to evaluate the potential of BHB supplementation as a novel strategy to impede the development and progression of intestinal adenomas in individuals with FAP, thus potentially reducing the need for frequent upper endoscopies and colonoscopies and preventing the need for risk-reducing surgical intervention.",[37,103],[37,137,138,139,140,141],"Familial adenomatous polyposis","Chemoprevention","Polyps","BHB","Beta-hydroxybutyrate","2025-08-27",{"date":144,"type":55},"2025-09-04",{"date":146,"type":55},"2024-09-20",{"date":148,"type":20},"2027-10",{"name":150,"class":121},"Abramson Cancer Center at Penn Medicine",1,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":160,"targetDuration":162,"studyType":99,"phases":4,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":122},"100569186","prostate-specific-membrane-antigen-petct-imaging-in-psma-related-disease-patients-100569186","NCT06690970","Prostate Specific Membrane Antigen PET\u002FCT Imaging in PSMA-Related Disease Patients","Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PSMA PET\u002FCT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.",true,"80 Years",{"count":161,"type":20},500,"7 Days","To evaluate the potential usefulness of 68Ga\u002F18F-PSMA\u002FPSFA positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various PSMA-related disease patients.",[165,39,166,167,37],"PSMA-related Disease","Positron Emission Tomography","Metastasis",[169,170,37],"PET\u002FCT","PSMA","2025-08-07",{"date":173,"type":55},"2025-08-11",{"date":175,"type":55},"2020-09-01",{"date":177,"type":20},"2027-12-01",{"name":179,"class":121},"Tianjin Medical University",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":151},"100506391","68ga-fapi-lm3-petct-imaging-in-patients-with-fapsstr2-positive-disease-and-compared-with-18f-fdg-100506391","NCT05873777","68Ga-FAPI-LM3 PET\u002FCT Imaging in Patients With FAP\u002FSSTR2 Positive Disease and Compared With 18F-FDG","Inclusion Criteria:\n\n* (i) adult patients (aged 18 years or order);\n* (ii) patients with suspected or newly diagnosed or previously malignant disease, with either FAP or SSTR2 positive expression (supporting evidence may include MRI, CT, and pathology report etc);\n* (iii) patients who had scheduled both 18F-FDG and 68Ga-FAPI-LM3 PET\u002FCT scans;\n* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n* (i) patients with non-malignant disease;\n* (ii) patients with pregnancy;\n* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.",{"count":187,"type":20},30,[133],"As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-LM3 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of lesions in SSTR2 positive diseases, and compared with 18F-FDG PET\u002FCT.",[191,37,192],"SSTR2","Positron-Emission Tomography",[191,37,192],"2025-08-05",{"date":196,"type":55},"2025-08-08",{"date":198,"type":55},"2023-04-09",{"date":200,"type":20},"2025-12-31",{"name":202,"class":121},"The First Affiliated Hospital of Xiamen University",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":151},"100545858","early-phase-1-68ga-psfa-pet-imaging-in-patients-with-psmafap-positive-disease-100545858","NCT06387381","68Ga-PSFA PET Imaging in Patients With PSMA\u002FFAP Positive Disease","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Signed informed consent.\n3. Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).\n\nExclusion Criteria:\n\n1. Patients with non-malignant disease.\n2. Patients with pregnancy.\n3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.\n4. Known or expected hypersensitivity to 68Ga-PSFA or any of its components.\n5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.",{"count":187,"type":20},[211],"EARLY_PHASE1","As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA\u002FFAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA\u002FFAP positive diseases.",[170,37,192],"2025-05-29",{"date":216,"type":55},"2025-06-04",{"date":218,"type":55},"2024-05-20",{"date":220,"type":20},"2026-12-31",{"name":222,"class":121},"First Affiliated Hospital of Chongqing Medical University",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":158,"sex":16,"minAge":231,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":244,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100586138","from-inflammation-to-remodelling-towards-personalized-diagnosis-in-post-acute-sequelae-of-covid-19-100586138","NCT06911476","From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19","From Inflammation Biomarkers to Remoddeling (FAPI PET\u002FCT) Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19","LIBERATE","Inclusion Criteria:\n\n\\- Self-reported complaints of dyspnea or fatigue \\> 3 months after SARS-CoV-2 infection confirmed with PCR, serology test or COVID-19 Reporting and Data System (CO-RADS) score 4\u002F5.\n\nExclusion Criteria:\n\n* Inability or unwilling to give informed consent.\n* History of claustrophobia or feeling of inability to tolerate supine position for the PET\u002FCT scans.\n* Individuals who are pregnant or currently breastfeeding are not eligible to participate","20 Years",{"count":233,"type":20},60,"Rationale: The diagnosis and pathogenesis of long COVID remains unknown. We have previously shown that \\[68Ga\\]FAPI Positron Emission Tomography-Computed Tomography (PET\u002FCT) imaging shows potential for diagnosis and molecular understanding of this syndrome. We have previously shown that fibroblast activation protein (FAP) can be imaged in the lung, muscle and nasopharynx of long COVID patients (with dyspnea and fatigue). However, these preliminary data are derived from a selective group of patients with long COVID after critical COVID-19. We aim to explore the generalizability of these findings in patients with long COVID with dyspnea and fatigue, irrespective of the severity of their acute SARS-CoV-2 infection.\n\nPrimary objective: To assess if pulmonary fibroblast activity, measured by \\[68Ga\\]FAPI-46 PET\u002FCT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.\n\nStudy design: This is a ZonMw funded single centre prospective observational cohort study of long COVID-19 patients with dyspnea and fatigue.\n\nStudy population: We will recruit 60 adult long COVID patients (aged \\>20 years) of which 30 have complaints of dyspnea and fatigue and compare them to 30 patients with resolved complaints and healthy controls.\n\nMain study parameters\u002Fendpoints: The primary endpoint is FAP expression in the lung measured by \\[68Ga\\]FAPI-46 PET\u002FCT. Secondary endpoints are the expression of FAP in other tissues (muscle) and the relation between FAP and inflammation and remodelling biomarkers in various biological samples (e.g. serum\u002Fnasal epithelium).\n\nStudy procedures: In a single visit day the following data and samples will be collected: questionnaires, a lung function test, 6-minute walking test, blood samples, nose swabs, \\[68Ga\\]FAPI PET\u002FCT scan and HRCT scan. When increased \\[68Ga\\]FAPI uptake is measured in the muscles a muscle biopsy will be performed as well.",[236,237,238,239,240,37,241,242,243],"PASC Post Acute Sequelae of COVID 19","Long COVID","Long Covid-19","PASC","FAPI","Fibroblast Activation Protein Inhibitor","Fibroblast","Restrictive Lung Disease","NOT_YET_RECRUITING","2025-04-03",{"date":247,"type":55},"2025-04-04",{"date":249,"type":20},"2025-05",{"date":251,"type":20},"2025-12",{"name":253,"class":121},"University Medical Center Groningen",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100576216","phase-2-multicenter-validation-trial-of-18falf-fapi-74-for-pet-imaging-of-cancer-associated-fibroblasts-through-fibroblast-activation-protein-inhibitors-fapi-in-different-tumor-types-100576216","NCT06782412","Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types","FAPIDO","Inclusion Criteria OGA:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT.\n5. TNM classification: cT1-4N0-3M0\n\nInclusion Criteria PDAC:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT or conventional staging with CT or MRI.\n5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.\n\nInclusion Criteria Clinically challenging cohort:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. Histologic or cytologic proven diagnosis of a malignancy.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT.\n5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.\n\nExclusion Criteria:\n\n1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.\n2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).\n5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n7. Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients.",{"count":262,"type":20},109,[24,264],"PHASE3","The aim of the project is to demonstrate superior detection ratio of \\[18F\\]AlF-FAPI-74 PET\u002FCT compared to \\[18F\\]FDG PET\u002FCT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \\[18F\\]AlF-FAPI-74 PET\u002FCT in oncological patients with a clinically challenging situation.",[267,268,269,37,270,271],"Oesophageal Cancer","Gastric Cancer","Pancreatic Ductal Adenocarcinoma","Oncology","Oncologic Disorders",[273,274,275,276,277,278,279,280,281,270,282],"Oesophagogastric adenocarcinoma","Pancreatic ductal adenocarcinoma","Clinically challenging situations","[18F]-FDG","[18F]-FAPI-74","[18F]AIF-FAPI-74","Positron emission tomography","PET","Nuclear imaging","Prospective","2025-02-06",{"date":285,"type":55},"2025-02-07",{"date":283,"type":55},{"date":288,"type":20},"2027-12",{"name":290,"class":121},"KU Leuven",3,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":151},"100570811","video-capsule-examination-in-patients-with-lynch-syndrome-100570811","NCT06712095","Video Capsule Examination in Patients With Lynch Syndrome","Video Capsule Examination in Patients With Lynch and Other Cancer-predisposition Syndromes - a Proof-of-concept Study for Obtaining Data to Support the Development of Machine Learning Algorithms to Detect Early Cancers","PILLCAM","Inclusion Criteria:\n\n* Patients over the age of 18 years old with no active cancer\n* No previous resection of the colon and\u002For rectum\n* Carriers of a pathogenic\u002Flikely pathogenic variant in any of the following cancer-predisposition genes: Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP syndrome); biallelic MUTYH; STK11 (Peutz-Jeghers syndrome); PTEN, CDH1, CHEK2, TP53, BMPR1A and SMAD4 (Juvenile polyposis syndrome)\n* Able to consent to the study and undergo colonoscopy.\n\nExclusion Criteria:\n\n* Extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. Extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract.\n* Previous irradiation to abdomen or pelvis (risk for small bowel obstruction)\n* Carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance.\n* Patients with a PS of 3 or 4 and\u002For mobility issues\n* Pregnancy\n* Pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device).\n* Insulin-dependent diabetes\n* Patients who require deep sedation for colonoscopy",{"count":301,"type":20},25,[133],"Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.\n\nThe main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.\n\nAt recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.\n\nIf the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.",[305,306,307,37,308,309,310,311,312,313],"Lynch Syndrome","Li Fraumeni Syndrome","PTEN Hamartoma Syndrome","MUTYH Biallelic Mutation","STK11 Mutation","CDH1 Gene Mutation","CHEK2 Gene Mutation","BMPR1A Gene Mutation","SMAD4 Gene Mutation","2024-12-03",{"date":316,"type":55},"2024-12-05",{"date":318,"type":55},"2024-03-04",{"date":83,"type":20},{"name":321,"class":121},"Royal Marsden NHS Foundation Trust",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":339,"locationsCount":151},"100558935","18f-fapi-04-petct-and-petmr-in-patients-with-various-types-of-malignant-tumors-100558935","NCT06557590","18F-FAPI-04 PET\u002FCT and PET\u002FMR in Patients With Various Types of Malignant Tumors","Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET\u002FCT and PET\u002FMR in Patients With Various Types of Malignant Tumors","Inclusion Criteria:\n\npatients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\npatients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.","90 Years",{"count":161,"type":20},"To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and positron emission tomography\u002Fmagnetic resonance imaging （PET\u002FMR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.",[27,37],"2024-08-14",{"date":335,"type":55},"2024-08-16",{"date":337,"type":55},"2024-01-01",{"date":85,"type":20},{"name":340,"class":121},"Hunan Cancer Hospital",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":356,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":151},"100530671","phase-2-role-of-the-fibroblast-activation-protein-fap-as-biomarker-of-fibrotic-lung-diseases-100530671","NCT06189820","Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases","FAPIPET","Inclusion Criteria:\n\n* Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic ILD) as defined according to the 2022 ATS\u002FERS\u002FJRS\u002FALAT Clinical Practice Guidelines\n\nExclusion Criteria:\n\n* Pregnant or nursing patients\n* Patients with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.\n* Patients with an active lung neoplasm or any active neoplasm for blood samples",{"count":349,"type":20},70,[24],"To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET\u002FCT.",[353,354,355,37],"Pulmonary Fibrosis","Lung Fibrosis","Idiopathic Pulmonary Fibrosis",[357,37],"Pulmonary fibrosis","2023-12-18",{"date":360,"type":55},"2024-01-05",{"date":362,"type":55},"2023-03-09",{"date":364,"type":20},"2027-03-09",{"name":366,"class":121},"Erasme University Hospital"]