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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06049368
Collaborator
(none)
40
Enrollment
1
Arm
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-P16-093 PET/CT Imaging in the Salivary Gland
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-P16-093

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT06049368
Other Study ID Numbers:
  • PUMCH-PSS093
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sjogren's Syndrome

Study Results

No Results Posted as of Sep 22, 2023