Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2022
CompletedFirst Submitted
Initial submission to the registry
February 19, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2025
CompletedDecember 27, 2024
December 1, 2024
3 years
February 19, 2023
December 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Al18F-PSMA-BCH PET/CT
EXPERIMENTALAl18F-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.）
Interventions
Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.
Eligibility Criteria
You may qualify if:
- 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.
- Age is 18 or older; No gender limitation.
- Signed the informed consent.
- Willing and able to cooperate with all projects in this study.
You may not qualify if:
- 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
- Claustrophobia.
- Pregnant or lactation women.
- Received experimental drug or device within 1 month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chaoyang, 100029, China
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Rong Zheng, MD
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2023
First Posted
March 9, 2023
Study Start
October 13, 2022
Primary Completion
October 13, 2025
Study Completion
October 13, 2025
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share