- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887687
68Ga-P3 PET/CT Imaging in Malignancy
A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors
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; 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.
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 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.
|
68Ga-P3 is injected intravenously with a dose of 0.06-0.08
mCi/kg.
Other Names:
|
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 malignant tumors
Time Frame: 1 year
|
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-P3 and 18F-FDG PET/CT
|
1 year
|
The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
Time Frame: 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.
|
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
|
Quantitative evaluation of 68Ga-P3
Time Frame: 1 year
|
Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve.
|
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
|
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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