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NCT05761366 Clinical Trial

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

Malignancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05761366
Other study ID # NCC3688
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 13, 2022
Est. completion date October 13, 2025

Study information
Verified date March 2024
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Xin Cheng, MD
Phone 15120002998
Email cxpumc@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date October 13, 2025
Est. primary completion date October 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Al18F-PSMA-BCH PET/CT
Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.

Locations
Country Name City State
China National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Chaoyang

Sponsors (1)
Lead Sponsor Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic value 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
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