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Clinical Trials/NCT05887687
NCT05887687
Recruiting
Not Applicable

A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors

Peking University First Hospital1 site in 1 country350 target enrollmentMay 20, 2023
ConditionsNeoplasms
Interventions[68Ga]P3

Overview

Phase
Not Applicable
Intervention
[68Ga]P3
Conditions
Neoplasms
Sponsor
Peking University First Hospital
Enrollment
350
Locations
1
Primary Endpoint
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

[68Ga]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Detailed Description

Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Registry
clinicaltrials.gov
Start Date
May 20, 2023
End Date
July 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xing YANG

Principal Investigator

Peking University First Hospital

Eligibility Criteria

Inclusion Criteria

  • patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent

Exclusion Criteria

  • Pregnant and lactating women; Female patients plan to become pregnant within 6 months.

Arms & Interventions

[68Ga]P3

Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-P3 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.

Intervention: [68Ga]P3

Outcomes

Primary Outcomes

The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors

Time Frame: 1 year

Compare the standardized Uptake Value (SUV) of lesions on 68Ga-P3 and 18F-FDG PET/CT

The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors

Time Frame: 1 year

Compare the number of lesions detected by 68Ga-P3 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.

Secondary Outcomes

  • The dosimetry of 68Ga-P3(1 year)
  • Correlation with pathological expression(1 year)
  • Quantitative evaluation of 68Ga-P3(1 year)

Study Sites (1)

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