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PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
11C-Choline
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring PSMA

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[68Ga] P137

Arm Description

Imaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]P137 PET/CT scans.

Outcomes

Primary Outcome Measures

SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)on PET/CT

Secondary Outcome Measures

ROC
The curve of the relationship between sensitivity and specificity

Full Information

First Posted
September 18, 2020
Last Updated
March 27, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04560725
Brief Title
PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer
Official Title
PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed Description
Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease. [68Ga]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on [68Ga]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSMA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[68Ga] P137
Arm Type
Experimental
Arm Description
Imaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]P137 PET/CT scans.
Intervention Type
Drug
Intervention Name(s)
11C-Choline
Other Intervention Name(s)
11C-CH
Intervention Description
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
Primary Outcome Measure Information:
Title
SUV
Description
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)on PET/CT
Time Frame
2 years
Secondary Outcome Measure Information:
Title
ROC
Description
The curve of the relationship between sensitivity and specificity
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, Professor
Phone
010-88196495
Email
pekyz@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhu, Associate Professor
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teli Liu
Phone
010-88196196
Email
liuteli123321@163.com
First Name & Middle Initial & Last Name & Degree
Yanan Ren
Phone
18286135605
Email
1913282072@qq.com
First Name & Middle Initial & Last Name & Degree
Hua Zhu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34453203
Citation
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.
Results Reference
derived

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PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer

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