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NCT Number: NCT05887687

68Ga-P3 PET/CT Imaging in Malignancy

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.

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Key information

Conditions

Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[68Ga]P3

Drug

68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Other names: [68Ga]-P3, PSMA specific PET imaging

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. Quantitative evaluation of 68Ga-P3

    Time frame: 1 year

    Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.

  3. Correlation with pathological expression

    Time frame: 1 year

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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