Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT06049368
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-P16-093 PET/CT Imaging in the Salivary Gland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093'}], 'secondaryOutcomes': [{'measure': 'standardized uptake value (SUV) of lesion', 'timeFrame': 'through study completion, an average of 1 year]', 'description': 'comparing the SUVmax of different grades in salivary gland lesion, derived from 68Ga-P16-093'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Sjögren Syndrome']}, 'descriptionModule': {'briefSummary': "Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.", 'detailedDescription': "Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathological diagnosis confirmed by operation or biopsy.\n* Obtain written informed consent and accepted follow-up.\n\nExclusion Criteria:\n\n* Pregnant, lactating women or having parenting plans during the study\n* Head and neck radiotherapy history ;\n* Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.\n* Other situaition researchers considered it was not appropriate to participate in trials.'}, 'identificationModule': {'nctId': 'NCT06049368', 'briefTitle': '68Ga-P16-093 PET/CT Imaging in the Salivary Gland', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '68Ga-P16-093 PET/CT Imaging in the Salivary Gland', 'orgStudyIdInfo': {'id': 'PUMCH-PSS093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-P16-093', 'description': 'Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093.', 'interventionNames': ['Drug: 68Ga-P16-093']}], 'interventions': [{'name': '68Ga-P16-093', 'type': 'DRUG', 'description': 'Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT.', 'armGroupLabels': ['68Ga-P16-093']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhaohui Zhu, MD', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '86-13611093752'}, {'name': 'Jialin Xiang', 'role': 'CONTACT', 'email': 'jialinx29@126.com', 'phone': '86-13051615100'}], 'overallOfficials': [{'name': 'Zhaohui Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}