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

Phase 1

Not yet recruiting

• Conditions: Primary Sjögren Syndrome
• Interventions: Drug: 68Ga-P16-093

• Registration Number: NCT06049368
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Study Start: 2023-10-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-P16-093	68Ga-P16-093	Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	through study completion, an average of 1 year	evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093

Secondary Outcome Measures

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