RecruitingEarly Phase 1NCT05365802

FAPI PET for Lung Fibrosis

PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.


Sponsor

University of California, Los Angeles

Enrollment

30 participants

Start Date

Nov 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD). The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease. The study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung. The study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview. Participants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan and one High Resolution CT of the lungs. The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special PET scan tracer called FAPI to image lung fibrosis (scarring of the lung) and better understand how interstitial lung disease (ILD) progresses and responds to treatment. It aims to improve the use of imaging as a tool to track this serious lung condition. You may be eligible if... - You have been confirmed to have interstitial lung disease (ILD) by CT scan - You are 18 years of age or older - You have recently started (or are about to start) a new ILD medication within 3 months of enrollment, OR you are scheduled for a lung biopsy or surgery You may NOT be eligible if... - You are pregnant or nursing - You have an active infectious lung disease - You are not expected to comply with the study procedures or follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-FAPi-46

Radiopharmaceutical will be administered via IV

PROCEDUREComputed Tomography

As part of PET/CT scan

PROCEDUREPositron Emission Tomography

As part of PET/CT scan

PROCEDUREHigh Resolution Computed Tomography

Will be conducted immediately after FAPI PET/CT


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT05365802


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