68Ga-P3 PET/CT Imaging in Malignancy
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent
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
Correlation with pathological expression 1 year Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens
Quantitative evaluation of 68Ga-P3 1 year Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China