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18F-FAPI-RGD PET/CT in Various Tumor Types

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06094530
Collaborator
(none)
100
Enrollment
1
Location
17.7
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the final diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT findings.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types
    Actual Study Start Date :
    Apr 10, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors [1 month]

      Tracer uptake in normal organs (background) is quantified by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with clinically suspected or diagnosed tumors
    Exclusion Criteria:

    • Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg

    • Complicated with chronic liver disease, myocardial infarction, stroke

    • Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception

    • Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departments of Nuclear Medicine, Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    • Study Director: Hao Wang, Doctor, Sichuan Provincial People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06094530
    Other Study ID Numbers:
    • SichuanPPH-cancers
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 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 Oct 23, 2023