68Ga-P3 PET/CT Imaging in Malignancy

November 5, 2024 updated by: Xing YANG, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [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.
Drug: [68Ga]P3
68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Other Names:
  • [68Ga]-P3
  • PSMA specific PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dosimetry of 68Ga-P3
Time Frame: 1 year
Research on the dose distribution of 68Ga-P3 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
1 year
Quantitative evaluation of 68Ga-P3
Time Frame: 1 year
Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
1 year
Correlation with pathological expression
Time Frame: 1 year
Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [68Ga]P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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