Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT06675357
Status:
SUSPENDED
Last Update Posted:
2025-11-20
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using FAPI PET/MRI to Evaluate Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Protocol Modifications', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of FAPI for lesion detection', 'timeFrame': 'Duration of scan, up to 80 minutes', 'description': 'Sensitivity and specificity for lesion detection on FAPI will be compared with that of PSMA PET, using a composite reference standard (all available histology, follow up clinical/standard of care imaging, serum PSA).'}, {'measure': 'Lesion FAPI uptake on PET', 'timeFrame': 'Duration of scan, up to 80 minutes', 'description': 'FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.'}, {'measure': 'Total FAPI-positive tumor volume change', 'timeFrame': 'Duration of scan, up to 80 minutes', 'description': 'The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer Metastatic Disease', 'Prostate Cancers']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.\n\nParticipants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Able and willing to provide informed consent\n* Known diagnosis of prostate cancer\n* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET\n* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.\n* Willing and able to undergo PET/MRI as part of this research\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Contraindication(s) to or inability to undergo PET/MRI\n* Participants for whom PET/MRI will delay timely delivery of treatment\n* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:\n* Have their own prescription for the medication\n* The informed consent process is conducted prior to the self-administration of this medication\n* Come to the research visit with a driver'}, 'identificationModule': {'nctId': 'NCT06675357', 'briefTitle': 'Using FAPI PET/MRI to Evaluate Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer', 'orgStudyIdInfo': {'id': '2024-0747'}, 'secondaryIdInfos': [{'id': 'A539300', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 8/4/25', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UW24045', 'type': 'OTHER', 'domain': 'UWCCC OnCore ID'}, {'id': 'Prostate SPORE', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fibroblast activation protein inhibitor (FAPI)', 'description': 'FAPI radiotracer will be used during PET', 'interventionNames': ['Radiation: FAPI', 'Procedure: Positron Emission Tomography (PET)', 'Procedure: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'FAPI', 'type': 'RADIATION', 'description': '5 +/- 2 mCi of Ga-FAPI-46', 'armGroupLabels': ['Fibroblast activation protein inhibitor (FAPI)']}, {'name': 'Positron Emission Tomography (PET)', 'type': 'PROCEDURE', 'description': 'Undergo PET scan', 'armGroupLabels': ['Fibroblast activation protein inhibitor (FAPI)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'description': 'Undergo MRI scan', 'armGroupLabels': ['Fibroblast activation protein inhibitor (FAPI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ali Pirasteh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}