68Ga-P3 PET/CT Imaging in Malignancy

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887687
• Other study ID #: [68Ga]P3
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: Peking University First Hospital
• Contact: Xing Yang, Dr.
• Phone: +861083572928
• Email: yangxing2017[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• [68Ga]P3
68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Quantitative evaluation of 68Ga-P3	Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.	1 year
Secondary	Correlation with pathological expression	Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens	1 year