Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-29 @ 4:23 PM
Study NCT ID:
NCT05761366
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-10-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malignancy', 'Prostate Specific Membrane Antigen Positive Tumor'], 'conditions': ['Malignancy']}, 'descriptionModule': {'briefSummary': 'In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.', 'detailedDescription': 'Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.\n2. Age is 18 or older; No gender limitation.\n3. Signed the informed consent.\n4. Willing and able to cooperate with all projects in this study.\n\nExclusion Criteria:\n\n1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc\n2. Claustrophobia.\n3. Pregnant or lactation women.\n4. Received experimental drug or device within 1 month.'}, 'identificationModule': {'nctId': 'NCT05761366', 'briefTitle': 'Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor', 'orgStudyIdInfo': {'id': 'NCC3688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Al18F-PSMA-BCH PET/CT', 'description': 'Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.）', 'interventionNames': ['Drug: Al18F-PSMA-BCH PET/CT']}], 'interventions': [{'name': 'Al18F-PSMA-BCH PET/CT', 'type': 'DRUG', 'otherNames': ['18F-Thretide PET/CT'], 'description': 'Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.', 'armGroupLabels': ['Al18F-PSMA-BCH PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Chaoyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Cheng, MD', 'role': 'CONTACT', 'email': 'cxpumc@foxmail.com', 'phone': '15120002998'}], 'facility': 'National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xin Cheng, MD', 'role': 'CONTACT', 'email': 'cxpumc@foxmail.com', 'phone': '15120002998'}, {'name': 'Guozhu Hou, MD', 'role': 'CONTACT', 'email': '15611145656@163.com', 'phone': '15611145656'}], 'overallOfficials': [{'name': 'Rong Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}