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68Ga-P3 PET/CT Imaging in Malignancy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05887687
Enrollment
350
Registered
2023-06-05
Start date
2023-05-20
Completion date
2025-07-31
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

[68Ga]P3, PSMA, PET/CT, Neoplasms

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.

Interventions

68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors1 yearCompare 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 tumors1 yearCompare 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

MeasureTime frameDescription
The dosimetry of 68Ga-P31 yearResearch 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-P31 yearEvaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
Correlation with pathological expression1 yearAnalyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

Countries

China

Contacts

Primary ContactXing Yang, Dr.
yangxing2017@bjmu.edu.cn+861083572928

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026