68Ga-P3 PET/CT Imaging in Malignancy

Not Applicable

Recruiting

• Conditions: Neoplasms
• Interventions: Drug: [68Ga]P3

• Registration Number: NCT05887687
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study Start: 2023-05-20
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]P3	[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.

Primary Outcome Measures

Name	Time	Method
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors	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	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 Outcome Measures

Name	Time	Method
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
Quantitative evaluation of 68Ga-P3	1 year	Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
Correlation with pathological expression	1 year	Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China