Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-03-21 @ 2:11 PM
Study NCT ID:
NCT05940259
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2023-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-P3 PET/CT Imaging in Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate', 'timeFrame': '1 year', 'description': 'the standardized Uptake Value (SUV) of lesions on 68Ga-P3 PET/CT'}, {'measure': 'The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate', 'timeFrame': '1 year', 'description': 'the number of lesions detected by 68Ga-P3 PET/CT, based on the pathology or clinical follow-up as gold standard.'}], 'secondaryOutcomes': [{'measure': 'The dosimetry of 68Ga-P3', 'timeFrame': '1 year', 'description': 'Research on the dose distribution of 68Ga-P3 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software'}, {'measure': 'Quantitative evaluation of 68Ga-P3', 'timeFrame': '1 year', 'description': 'Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens'}, {'measure': 'Correlation with pathological expression', 'timeFrame': '1 year', 'description': 'Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['[68Ga]P3', 'PSMA', 'PET/CT', 'Neoplasms'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\n\n\\[68Ga\\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.', 'detailedDescription': 'Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\\[68Ga\\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with confirmed or suspected cancer; Signed written informed consent\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05940259', 'briefTitle': '68Ga-P3 PET/CT Imaging in Prostate', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate', 'orgStudyIdInfo': {'id': '[68Ga] P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[68Ga]P3', 'description': 'Subjects with suspected or confirmed Prostate will receive an intravenous injection of 68Ga-P3 followed by PET imaging.', 'interventionNames': ['Drug: [68Ga]P3']}], 'interventions': [{'name': '[68Ga]P3', 'type': 'DRUG', 'otherNames': ['[68Ga]-P3', 'PSMA specific PET imaging'], 'description': '68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.', 'armGroupLabels': ['[68Ga]P3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xing Yang', 'role': 'CONTACT', 'email': 'yangxing2017@bjmu.edu.cn', 'phone': '+861083572928'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xing Yang, Dr.', 'role': 'CONTACT', 'email': 'yangxing2017@bjmu.edu.cn', 'phone': '+861083572928'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xing YANG', 'investigatorAffiliation': 'Peking University First Hospital'}}}}