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Clinical Trials/NCT05940259
NCT05940259
Recruiting
Not Applicable

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

Peking University First Hospital1 site in 1 country30 target enrollmentMay 29, 2023
ConditionsNeoplasms
Interventions[68Ga]P3

Overview

Phase
Not Applicable
Intervention
[68Ga]P3
Conditions
Neoplasms
Sponsor
Peking University First Hospital
Enrollment
30
Locations
1
Primary Endpoint
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate
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 29, 2023
End Date
July 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

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; Signed written informed consent

Exclusion Criteria

  • Not provided

Arms & Interventions

[68Ga]P3

Subjects with suspected or confirmed Prostate will receive an intravenous injection of 68Ga-P3 followed by PET imaging.

Intervention: [68Ga]P3

Outcomes

Primary Outcomes

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

Time Frame: 1 year

the standardized Uptake Value (SUV) of lesions on 68Ga-P3 PET/CT

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

Time Frame: 1 year

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

Secondary Outcomes

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

Study Sites (1)

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