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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05761366
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Al18F-PSMA-BCH PET/CT
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
Actual Study Start Date :
Oct 13, 2022
Anticipated Primary Completion Date :
Oct 13, 2024
Anticipated Study Completion Date :
Oct 13, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic value [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Chaoyang China 100029

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05761366
    Other Study ID Numbers:
    • NCC3688
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Malignancy
    Prostate Specific Membrane Antigen Positive Tumor
    Additional relevant MeSH terms:
    Neoplasms
    PSMA-BCH

    Study Results

    No Results Posted as of Mar 9, 2023