68Ga-P16-093 PET/CT Imaging in the Salivary Gland
Overview
- Phase
- Phase 1
- Intervention
- 68Ga-P16-093
- Conditions
- Primary Sjögren Syndrome
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 40
- Primary Endpoint
- Diagnostic performance
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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.
Arms & Interventions
68Ga-P16-093
Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093.
Intervention: 68Ga-P16-093
Outcomes
Primary Outcomes
Diagnostic performance
Time Frame: through study completion, an average of 1 year
evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093
Secondary Outcomes
- standardized uptake value (SUV) of lesion(through study completion, an average of 1 year])