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Clinical Trial NCT05887687 for Neoplasms is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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68Ga-P3 PET/CT Imaging in Malignancy 350 Novel Treatment
Clinical Trial NCT05887687 is an interventional study for Neoplasms that is recruiting. It started on 20 May 2023 with plans to enroll 350 participants. Led by Peking University First Hospital, it is expected to complete by 31 July 2025. The latest data from ClinicalTrials.gov was last updated on 7 November 2024.
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 wid...
Show MoreDetailed 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 ...Show More
Official Title
A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors
Conditions
NeoplasmsOther Study IDs
- [68Ga]P3
NCT ID Number
Start Date (Actual)
2023-05-20
Last Update Posted
2024-11-07
Completion Date (Estimated)
2025-07-31
Enrollment (Estimated)
350
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
[68Ga]P3
PSMA
PET/CT
Neoplasms
PSMA
PET/CT
Neoplasms
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / 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 68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Quantitative evaluation of 68Ga-P3 | Evaluation of quantitative parameters of 68Ga-P3, such as time-activity curve. | 1 year |
Correlation with pathological expression | Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens | 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent
Pregnant and lactating women; Female patients plan to become pregnant within 6 months.
Peking University First HospitalStudy Responsible Party
Xing YANG, Principal Investigator, Principal Investigator, Peking University First Hospital
Study Central Contact
Contact: Xing Yang, Dr., +861083572928, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Peking University First Hospital, Beijing, Beijing Municipality, 100034, China
Xing Yang, Contact, +861083572928, [email protected]
Recruiting