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Clinical trial

68Ga-P16-093 PET/CT Imaging in the Salivary Gland

ID
Name
PUMCH-PSS093
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2023-12-30
Trial end
2024-03-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
68Ga-P16-093
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.
Arms:
68Ga-P16-093
Size
40
Primary endpoint
Diagnostic performance
through study completion, an average of 1 year
Eligibility criteria
Inclusion Criteria: * pathological diagnosis confirmed by operation or biopsy. * Obtain written informed consent and accepted follow-up. Exclusion Criteria: * Pregnant, lactating women or having parenting plans during the study * Head and neck radiotherapy history ; * Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases. * Other situaition researchers considered it was not appropriate to participate in trials.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-09-22

1 organization

1 product

1 indication

Organization
Peking Union Medical College Hospital
Product
68Ga-P16-093
Indication
Primary Sjögren's Syndrome