NCT06049368

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 7, 2023

Last Update Submit

September 19, 2023

Conditions

Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • standardized uptake value (SUV) of lesion

    through study completion, an average of 1 year]

Study Arms (1)

68Ga-P16-093

EXPERIMENTAL

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

Drug: 68Ga-P16-093

Interventions

68Ga-P16-093DRUG

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.

68Ga-P16-093

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathological diagnosis confirmed by operation or biopsy.
  • Obtain written informed consent and accepted follow-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-1361109375213611093752@163.com

Jialin Xiang

CONTACT

86-13051615100jialinx29@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 22, 2023

Study Start

October 1, 2023

Primary Completion

December 30, 2023

Study Completion

March 31, 2024

Last Updated

September 22, 2023

Record last verified: 2023-09