An interventional study of [68Ga]P3 in Neoplasms, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 350 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.
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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.
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
68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Also known as: [68Ga]-P3, PSMA specific PET imaging
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
Time frame: 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.
Time frame: 1 year
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
Time frame: 1 year
Quantitative evaluation of 68Ga-P3
Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
Time frame: 1 year
Correlation with pathological expression
Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens
Time frame: 1 year
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