Clincosm LogoSign in Get a demo

Clinical Study of 18F-FAPI-RGD in Interstitial Lung Disease Associated With Connective Tissue Disease

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06143540
Collaborator
(none)
30
Enrollment
1
Location
10.5
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to examine clinical utility of 18F-FAPI-RGD PET/CT imaging in evaluating connective tissue disease-associated interstitial lung disease. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Interstitial lung disease is an overarching term for a wide range of disorders characterized by inflammation and/ or fibrosis in the lungs. Interstitial lung disease associated connective tissue diseases(CTD-ILD) is one of the most common types.The goal of this study is to explore the feasibility of using 18F-FAPI-RGD, a dual-targeting heterodimeric PET tracer that recognizes both fibroblast activation protein (FAP) and integrin αvβ3 for detecting connective tissue disease associated interstitial lung disease (CTD-ILD), and analyze the relationship between 18F- FAPI-RGD PET/CT images and related parameters of lung function, clinical laboratory indicators and HRCT scores.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Study of 18F Labeled Probe Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) in Interstitial Lung Disease Associated With Connective Tissue Disease
    Actual Study Start Date :
    Aug 16, 2023
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between clinical indicators and PET/CT results [2 months]

      Correlation of clinical pulmonary function indexes, HRCT, laboratory examination indexes and 18F-FAPI-RGD PET/CT results

    Eligibility Criteria

    Criteria

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

    • Age 18 and above

    • Patients who have been diagnosed with, or are clinically highly suspected of ILD

    • Patients who have been diagnosed with, or are clinically highly suspected of CTD-ILD

    Exclusion Criteria:

    • Pregnant or breastfeeding

    • Patients with tumor, other respiratory diseases, and lung surgery

    • Abnormal cardiopulmonary function or mental state, unable tolerate PET/CT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    None specified.

    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:
    NCT06143540
    Other Study ID Numbers:
    • SCPH-ILDCTD
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 24, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial
    Connective Tissue Diseases

    Study Results

    No Results Posted as of Nov 24, 2023