PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer
1 other identifier
interventional
50
1 country
1
Brief Summary
To study the radioactive uptake of \[68Ga\]P137 in the lesion sites of PCa patients and evaluate the ability of \[68Ga\]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Oct 2020
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 19, 2024
August 1, 2024
4.1 years
September 18, 2020
August 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
2 years
Secondary Outcomes (1)
ROC
2 years
Study Arms (1)
[68Ga] P137
EXPERIMENTALImaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo \[68Ga\]P137 PET/CT scans.
Interventions
11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the \[68Ga\]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT
Eligibility Criteria
You may qualify if:
- Men over 18 years of age need to undergo \[68Ga\]P137 PET/CT examination for suspected prostate cancer.
- The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.
You may not qualify if:
- Significant hepatic or renal dysfunction;
- Patients with malignant tumors other than prostate cancer within 2 years;
- Ready to pregnant;
- The patient can not tolerate all clinical tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (1)
Duan X, Cao Z, Zhu H, Liu C, Zhang X, Zhang J, Ren Y, Liu F, Cai X, Guo X, Xi Z, Pomper MG, Yang Z, Fan Y, Yang X. 68Ga-labeled ODAP-Urea-based PSMA agents in prostate cancer: first-in-human imaging of an optimized agent. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1030-1040. doi: 10.1007/s00259-021-05486-x. Epub 2021 Aug 28.
PMID: 34453203DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 23, 2020
Study Start
October 22, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share