[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-lobular-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-lobular-breast-carcinoma":31},{"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":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100643361","disease-extent-in-stage-iv-lobular-carcinoma-the-aid-of-imaging-and-liquid-biopsy-analyses-100643361","NCT07635654","Disease Extent in Stage IV Lobular Carcinoma: the Aid of Imaging and Liquid Biopsy Analyses","DELILA","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. ECOG from 0 to 2\n4. Patient with stage IV ILC, either de novo or after prior (curative) treatment for early ILC. Histological subtype confirmed on primary tumor or on metastatic tissue. Patients that are diagnosed with stage IV breast cancer that have a mixed ILC\u002FIBC-NST histology of the primary tumor (mixed histology within the same primary lesion) will also be able to participate and will be analyzed in an exploratory cohort.\n5. Confirmation of hormone receptor positive (HR+)\u002FHER2- disease either on new biopsy or archival tissue (e.g. primary tumor)\n6. Multifocal or bilateral disease is allowed if all evaluated foci present with HR+\u002FHER2- ILC\n7. Starting first line of treatment for metastatic ILC\n\nExclusion Criteria:\n\n1. Presence of a contraindication to perform WB-DWI\u002FMRI\n2. Presence of severe claustrophobia\n3. Presence of a contraindication to use IV contrast for CT or PET\u002FCT (e.g. allergy, severe renal failure) in case a non-contrast PET\u002FCT cannot be performed\n4. Patients considered to have oligometastatic disease who are expected to undergo locoregional treatment\n5. Presence of other malignancies in recent medical history (\\\u003C5 years)\n6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive\n7. Adults who are the subject of a legal protection measure or who are unable to express their consent.",{"count":57,"type":21},43,[59],"NA","Metastatic invasive lobular carcinoma (ILC) is a distinct breast cancer subtype characterized by loss of E-cadherin and a diffuse growth pattern that makes metastases difficult to detect with standard imaging such as computed tomography (CT) or 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET)\u002FCT. As a result, disease burden in patients with ILC is frequently underestimated, progression is identified later than clinically optimal, and many patients are excluded from clinical trials due to insufficiently measurable disease.\n\nWhole-body diffusion-weighted magnetic resonance imaging (WB-DWI\u002FMRI) is a radiation-free imaging technique that has demonstrated improved sensitivity for detecting metastases-including peritoneal, bone, and nodal disease-in ILC. Retrospective studies suggest that WB-DWI\u002FMRI can identify clinically relevant progression not visible on standard imaging. However, prospective evidence in ILC is lacking. Circulating tumor DNA (ctDNA) has also shown promise as a minimally invasive biomarker for monitoring treatment response, with early molecular changes often preceding radiologic progression, but data specific to ILC remain limited.\n\nThe DELILA study is a prospective, multicenter clinical trial conducted at University Hospitals Leuven and Institut Jules Bordet. The study aims to enroll 43 patients starting first-line systemic therapy for metastatic hormone receptor positive human epidermal growth factor receptor 2 negative (HR+\u002FHER2-) ILC. Participants undergo serial dual imaging-WB-DWI\u002FMRI and standard-of-care imaging-at baseline, at 1 month, and approximately every 3 months for up to 30 months or until disease progression. At each imaging time point, blood samples are collected for ctDNA analysis and Ca15.3 tumor marker assessment. Patient-reported psychological burden related to repeated imaging and blood sampling is evaluated using validated questionnaires.\n\nThe primary objective is to assess the added value of WB-DWI\u002FMRI in detecting disease progression that informs clinical decision-making compared to standard imaging. Secondary objectives include evaluating whether ctDNA or Ca15.3 dynamics reflect disease evolution, assessing measurability of lesions with Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and MRI-specific criteria, identifying early biomarkers of treatment response using Apparent Diffusion Coefficient (ADC) changes and ctDNA kinetics, and characterizing the psychological impact of trial procedures.\n\nThis study will provide the first adequately powered prospective evidence on the clinical utility of WB-DWI\u002FMRI and liquid biopsy monitoring in metastatic ILC. Results may support implementation of WB-DWI\u002FMRI as a routine imaging strategy, guide imaging frequency through biomarker-informed approaches, and improve patient experience and trial eligibility for individuals living with metastatic ILC.",[31],[63,64,65,66],"Invasive lobular carcinoma","Imaging","WB-DWI MRI","Liquid biopsy","NOT_YET_RECRUITING","2026-06-03",{"date":70,"type":40},"2026-06-09",{"date":72,"type":21},"2026-07-01",{"date":74,"type":21},"2030-06-30",{"name":76,"class":77},"KU Leuven","OTHER"]