[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
11C-Choline
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring PSMA
Eligibility Criteria
Inclusion Criteria:
- Men over 18 years of age need to undergo [Al18F]PSMA137 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
[Al18F]PSMA137 PET/CT imaging
Arm Description
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [Al18F]PSMA137 PET/CT scans.
Outcomes
Primary Outcome Measures
SUV(standardized uptake value)
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer ([Al18F]PSMA137) in the primary and metastatic tumor lesions by measuring SUV on PET/CT
Secondary Outcome Measures
Full Information
NCT ID
NCT04693169
First Posted
December 30, 2020
Last Updated
July 18, 2022
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT04693169
Brief Title
[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
Official Title
[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 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 investigate the radioactive uptake of [Al 18 F]PSMA137 in PCa patients, and evaluate the ability of [Al 18 F]PSMA137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).To provide an approach for screening patients high expression of PSMA, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.
Detailed Description
Prostate cancer (PCa) is the most common malignant tumor in the male reproductive system, and its prognosis and treatment mainly depend on the discovery of the primary disease and the early stage of metastasis, while traditional imaging and histological methods are difficult to meet the clinical requirements for the early diagnosis and accurate staging of PCa.Positron emission tomography (PET) has the characteristics of precision and non-invasive, so the development of PCa targeted molecular probe is of great significance for improving the specificity and accuracy of PCa diagnosis.
PSMA is a highly specific prostatic epithelial 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.
The radionuclides used for PET imaging include 18F (T 1/2 =109.8min), which has a suitable half-life and cyclotron preparation to enable the high yield synthesis of 18F labeled tracer, so it can be used in more patients and provided to other departments without on-site tracer production facilities.In addition, coordination labeling method is simple, easy to realize automatic synthesis technology and medicine box preparation.Therefore, 18F-labeled PSMA targeted molecular probe is a hot spot in the diagnosis of prostate cancer.
[Al18F]PSMA137 is a novel PSMA targeted tracer labeled with 18F. NOTA is used as a bifunctional chelating agent to facilitate better chelation with Al18F. It has a higher tumor uptake and a faster metabolism in normal organs with a lower background.[Al18F]PSMA137, as a novel targeted molecular probe, shows excellent properties in tumor cell uptake.This project provides research on [Al18F]PSMA137 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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[Al18F]PSMA137 PET/CT imaging
Arm Type
Experimental
Arm Description
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [Al18F]PSMA137 PET/CT scans.
Intervention Type
Drug
Intervention Name(s)
11C-Choline
Other Intervention Name(s)
11C-CH
Intervention Description
1、PSMA137 labeled with [Al18F] will be used as a molecular imaging tracer for PET/CT scanning。 2、11C-choline (0.05-0.1mCi/kg) was injected intravenously in a week after the [Al18F]PSMA137 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(standardized uptake value)
Description
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer ([Al18F]PSMA137) in the primary and metastatic tumor lesions by measuring SUV on PET/CT
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 [Al18F]PSMA137 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
Yanan Ren
Phone
010-88196495
Email
yananren123@126.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
010-88196196
Email
yananren123@126.com
First Name & Middle Initial & Last Name & Degree
Zhi Yang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
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