- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940259
68Ga-P3 PET/CT Imaging in Prostate
A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate
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.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xing Yang, Dr.
- Phone Number: +861083572928
- Email: yangxing2017@bjmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Recruiting
- Peking University first hospital
-
Contact:
- Xing Yang
- Phone Number: +861083572928
- Email: yangxing2017@bjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
patients with confirmed or suspected cancer; Signed written informed consent
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [68Ga]P3
Subjects with suspected or confirmed Prostate will receive an intravenous injection of 68Ga-P3 followed by PET imaging.
|
68Ga-P3 is injected intravenously with a dose of 0.06-0.08
mCi/kg.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate
Time Frame: 1 year
|
the standardized Uptake Value (SUV) of lesions on 68Ga-P3 PET/CT
|
1 year
|
The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate
Time Frame: 1 year
|
the number of lesions detected by 68Ga-P3 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
Time Frame: 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
|
1 year
|
Correlation with pathological expression
Time Frame: 1 year
|
Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens
|
1 year
|
Quantitative evaluation of 68Ga-P3
Time Frame: 1 year
|
Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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