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NCT06143540 Clinical Trial

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

Interstitial Lung Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06143540
Other study ID # SCPH-ILDCTD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 16, 2023
Est. completion date July 2024

Study information
Verified date November 2023
Source Sichuan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between clinical indicators and PET/CT results Correlation of clinical pulmonary function indexes, HRCT, laboratory examination indexes and 18F-FAPI-RGD PET/CT results 2 months
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