- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04693169
[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yanan Ren
- Phone Number: 010-88196495
- Email: yananren123@126.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
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 |
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Experimental: [Al18F]PSMA137 PET/CT imaging
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [Al18F]PSMA137 PET/CT scans.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SUV(standardized uptake value)
Time Frame: 2 years
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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
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2 years
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Collaborators and Investigators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Gastrointestinal Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Nootropic Agents
- Lipotropic Agents
- Choline
Other Study ID Numbers
- 2020KT154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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