Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT05558956
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2022-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.', 'timeFrame': '3 months', 'description': 'In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration-resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male ≥ 18 years of age\n3. Patients meeting clinical need for Illuccix PET scan:\n\n 1. Patients with suspected metastasis who are candidates for initial definitive therapy\n 2. Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level\n4. Patient is physically able to lay flat for the PET-CT procedure\n\nExclusion Criteria:\n\n1\\. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.'}, 'identificationModule': {'nctId': 'NCT05558956', 'briefTitle': 'Total Body PET-CT Imaging of Prostate Cancer Using Illuccix', 'organization': {'class': 'OTHER', 'fullName': 'BAMF Health'}, 'officialTitle': 'Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)', 'orgStudyIdInfo': {'id': 'BAMF-2022-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': '3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.', 'interventionNames': ['Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': '7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.', 'interventionNames': ['Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT']}], 'interventions': [{'name': 'illuccix 68Ga-PSMA-11 Total Body PET-CT', 'type': 'DRUG', 'description': 'Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11', 'armGroupLabels': ['High dose', 'Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Rogers', 'role': 'CONTACT', 'email': 'clinical.research@bamfhealth.com', 'phone': '616-330-3886'}], 'facility': 'BAMF Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'centralContacts': [{'name': 'Dan Rogers', 'role': 'CONTACT', 'email': 'clinical.research@bamfhealth.com', 'phone': '616-330-3886'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BAMF Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Telix Pharmaceuticals (Innovations) Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}