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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Sjögren Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-P16-093

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

Group Type EXPERIMENTAL

68Ga-P16-093

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No