Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT04800068
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-01-21
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access [Ga-68] PSMA-11 PET Imaging
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True, 'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials.', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'In this expanded access IND study, Mayo Clinic in Rochester MN offers \\[Ga-68\\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.', 'detailedDescription': '\\[Ga-68\\] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostate cancer and at the time of biochemical recurrence. In addition, available data show superiority of metastatic lesion detection with \\[Ga-68\\] PSMA-11 PET over conventional imaging. This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes.\n\nUnder expanded access IND, enrolled patients will receive a clinical \\[68Ga\\] PSMA-11 PET/CT or PET/MR for evaluation of their cancer. Imaging exams must be deemed clinically indicated by a referring provider. Patients will be responsible for the cost of the imaging exam. Access is limited.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'eligibilityCriteria': 'Participant Groups\n\nThere are two participant groups; please refer to the inclusion details below:\n\nGroup 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):\n\n1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more\n2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)\n3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)\n\nBiochemically Recurrent prostate cancer group (must meet one of the criteria):\n\n1. In patients who have undergone a prostatectomy, PSA \\> 0.2 ng/ml on 2 consecutive tests\n2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA\n\nExclusion Criteria: Current exclusion criteria for both groups includes:\n\n1. Patients unable to sign informed consent\n2. Patient with a life expectancy less than 6 months\n3. Additional exclusion criteria may be added based on demand'}, 'identificationModule': {'nctId': 'NCT04800068', 'briefTitle': 'Expanded Access [Ga-68] PSMA-11 PET Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Expanded Access [Ga-68] PSMA-11 PET Imaging', 'orgStudyIdInfo': {'id': '20-013358'}}, 'armsInterventionsModule': {'interventions': [{'name': '[Ga-68] PSMA-11 PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging scan'}, {'name': '[Ga-68] PSMA-11 PET/MR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging scan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Geoffrey Johnson', 'investigatorAffiliation': 'Mayo Clinic'}}}}