[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Blue Earth Diagnostics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100626207","phase-1-18ffpyqcp-pet-imaging-of-fibroblast-activation-protein-in-selected-oncology-indications-100626207",false,"NCT07432633","[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","A Phase 1\u002F2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","Inclusion Criteria:\n\n1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.\n2. Participants must be ≥ 18 years and \\\u003C 80 years of age and competent to give informed consent.\n3. Eastern Cooperative Oncology Group performance status ≤ 2.\n4. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).\n5. Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET\u002FCT imaging visit (Visit 2) prior to \\[18F\\]FPyQCP administration.\n6. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study\n7. Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease \\[5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of \\[18F\\]FPyQCP administration.\n8. Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before \\[18F\\]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.\n9. Either:\n\n   1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.\n   2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. \\[18F\\]FPyQCP PET\u002FCT imaging should be performed as close to scheduled procedure as clinically feasible.\n   3. Suspected recurrence after definitive therapy\n\nExclusion Criteria:\n\n1. Participants administered any radioisotope within 5 physical half-lives prior to \\[18F\\]FPyQCP administration.\n2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \\[18F\\]FPyQCP administration.\n3. Participants who have recently received any other contrast agent (\\\u003C 24 hours for intravenous agents and \\\u003C 5 days for oral agents) before the day of \\[18F\\]FPyQCP administration.\n4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n5. Known hypersensitivity to \\[18F\\]FPyQCP or any of its constituents.\n6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.\n7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).\n8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.\n9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.\n10. Significant renal or hepatic impairment.\n11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \\[18F\\]FPyQCP administration.\n12. Cohort A Specific Exclusion Criteria: 12. No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).","ALL","18 Years","80 Years",{"count":20,"type":21},71,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a multi-center, open-label, single-arm, Phase 1\u002F2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \\[18F\\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).",[28,29,30,31,32],"Colorectal Cancer","Epithelial Ovarian Cancer","Gastric Cancer","Invasive Lobular Breast Carcinoma","Pancreatic Ductal Adenocarcinoma",[34,35],"Positron emission tomography","Fibroblast activation protein","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":40},"2026-02-19",{"date":44,"type":21},"2028-01-31",{"name":46,"class":47},"Blue Earth Diagnostics","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100636764","phase-4-impact-of-fluciclovine-18f-pet-positron-emission-tomography-on-the-management-of-prostate-cancer-following-negative-or-equivocal-psma-prostate-specific-membrane-antigen-pet-imaging-at-the-time-of-biochemical-recurrence-100636764","NCT07569926","Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence","The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence","Inclusion Criteria:\n\n1. Participants must be males aged ≥18 years at Screening.\n2. Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 \\[fluciclovine (18F) PET\u002FCT scan\\]), regardless of findings on conventional imaging.\n3. Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng\u002FmL (completed \\>6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng\u002FmL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations.\n4. Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection.\n5. Participants must provide written informed consent before any study-specific procedures or interventions are performed.\n6. Ability of the participants to comply with planned study procedures\n\nExclusion Criteria:\n\n1. Participants with known metastatic castrate resistant prostate cancer.\n2. Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements.\n3. Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET\u002FCT scan.\n4. Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET\u002FCT scan.\n5. Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).\n6. Participants who have received salvage therapy for the current episode of BCR.\n7. Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET\u002FCT scans.","MALE",{"count":58,"type":21},142,[60],"PHASE4","The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence",[63],"Prostate Cancer",[63,65,66,67],"Biochemical Recurrence (BCR)","Positron Emission Tomography (PET) Scan","Negative or equivocal PSMA PET scan","NOT_YET_RECRUITING","2026-05-29",{"date":71,"type":40},"2026-06-02",{"date":73,"type":21},"2026-06-01",{"date":75,"type":21},"2032-12-31",{"name":46,"class":47},6,""]