68Ga-P3 PET/CT Imaging in Malignancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: [68Ga]P3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [68Ga]P3<br>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<br>* 68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.<br>* Other names: PSMA specific PET imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors | 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 | 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 | 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 | Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve. | 1 year | 
| Correlation with pathological expression | Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[68Ga]P3, PSMA, PET/CT, Neoplasms