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18F-FAPI PET/CT in Patients With Various Types of Cancer

Sponsor
Jilin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05810324
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
30.1
Anticipated Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Performance of 18F-FAPI PET/CT in Patients With Various Types of Cancer
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-FAPI

Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.

Drug: 18F-FAPI
Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.
Other Names:
  • FAPI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy [1 year]

      The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);

    • patients who had scheduled 18F-FAPI PET/CT scan; (iv)

    • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

    Exclusion Criteria:

    • patients with non-malignant lesions;

    • patients with pregnancy;

    • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China-Japan Union Hospital Chang chun Jilin China 130031

    Sponsors and Collaborators

    • Jilin University

    Investigators

    • Principal Investigator: Bin Ji, China-Japan Union Hospital, Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji Bin, Doctor, Jilin University
    ClinicalTrials.gov Identifier:
    NCT05810324
    Other Study ID Numbers:
    • ChinaJapanUHJLU
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 12, 2023