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

Primary Sjögren Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049368
• Other study ID #: PUMCH-PSS093
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 86-13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]