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

Study 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.

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

Conditions
-----------------
Primary Sjögren Syndrome

Intervention / Treatment
-----------------
* Drug: 68Ga-P16-093


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-P16-093<br>Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093. | Drug: 68Ga-P16-093<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance | evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093 | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standardized uptake value (SUV) of lesion | comparing the SUVmax of different grades in salivary gland lesion, derived from 68Ga-P16-093 | through study completion, an average of 1 year] |