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[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693169
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Hua Zhu, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 11C-Choline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : December 12, 2023
Estimated Study Completion Date : December 12, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 11C-Choline
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 Name: 11C-CH




Primary Outcome Measures :
  1. SUV(standardized uptake value) [ Time Frame: 2 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693169


Contacts
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Contact: Yanan Ren 010-88196495 yananren123@126.com
Contact: Hua Zhu, Associate Professor 010-88196495 zhuhuabch@pku.edu.cn

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Teli Liu    010-88196196    liuteli123321@163.com   
Contact: Yanan Ren    010-88196196    yananren123@126.com   
Principal Investigator: Zhi Yang         
Sponsors and Collaborators
Beijing Cancer Hospital
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Responsible Party: Hua Zhu, Associate Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04693169    
Other Study ID Numbers: 2020KT154
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hua Zhu, Beijing Cancer Hospital:
PSMA
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents