Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT04347135
Status:
WITHDRAWN
Last Update Posted:
2024-05-10
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No Enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Endometriosis', 'timeFrame': '24 months', 'description': 'Comparisons will be made descriptively between conventional MRI imaging, FES PET/MRI imaging and surgical/pathologic findings. Outcome data include number of detected lesions, differences in the accuracy for detection of active disease versus inactive fibrosis, and confidence score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Premenopausal women (18-50) with endometriosis\n\nExclusion Criteria:\n\n* Postmenopausal women\n* AP diameter when lying supine greater than 32 cm (too large for PET/MRI)\n* Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)\n* Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR \\< 60, contrast allergy)\n* Pregnant (Urine test will be provided for all patients)'}, 'identificationModule': {'nctId': 'NCT04347135', 'briefTitle': 'Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI', 'orgStudyIdInfo': {'id': '19-004345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F-18 FES PET/MRI', 'description': '16α-(18)F-fluoro-17β-estradiol (\\[F-18\\] FES)', 'interventionNames': ['Drug: F-18 FES']}], 'interventions': [{'name': 'F-18 FES', 'type': 'DRUG', 'description': 'F-18 FES PET/MRI for detection of endometriosis.', 'armGroupLabels': ['F-18 FES PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ann Packard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annie (Annie) T. Packard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Annie (Annie) T. Packard', 'investigatorAffiliation': 'Mayo Clinic'}}}}