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68Ga-P3 PET/CT Imaging in Prostate

Sponsor
Peking University First Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05940259
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
26.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate
Actual Study Start Date :
May 29, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: [68Ga]P3

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate [1 year]

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

    2. The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate [1 year]

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

    Secondary Outcome Measures

    1. The dosimetry of 68Ga-P3 [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

    2. Quantitative evaluation of 68Ga-P3 [1 year]

      Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

    3. Correlation with pathological expression [1 year]

      Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    patients with confirmed or suspected cancer; Signed written informed consent

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University First Hospital Beijing Beijing China 100034

    Sponsors and Collaborators

    • Peking University First Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xing YANG, Principal Investigator, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT05940259
    Other Study ID Numbers:
    • [68Ga] P3
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xing YANG, Principal Investigator, Peking University First Hospital
    [68Ga]P3
    PSMA
    PET/CT
    Neoplasms
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 11, 2023