Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor

December 21, 2024 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chaoyang
      • Beijing, Chaoyang, China, 100029
        • Recruiting
        • National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
  2. Age is 18 or older; No gender limitation.
  3. Signed the informed consent.
  4. Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

  1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
  2. Claustrophobia.
  3. Pregnant or lactation women.
  4. Received experimental drug or device within 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Al18F-PSMA-BCH PET/CT
Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.）
Drug: Al18F-PSMA-BCH PET/CT
Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.
Other Names:
  • 18F-Thretide PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: through study completion, an average of 1 year
Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Rong Zheng, MD, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Estimated)

October 13, 2025

Study Completion (Estimated)

October 13, 2025

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC3688

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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