Overview

FAPI PET for Lung Fibrosis

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

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 with fibrotic lesions who are scheduled to undergo lung biopsy or transplantation. 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. The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of California, Los Angeles

Treatments:

FAPI-46

Criteria

Inclusion Criteria:

Patients with the following ILD:

1. Idiopathic interstitial pneumonia

2. Connective tissue disease related intestitial lung disease (CTD-ILD)

3. Drug-induced pneumonitis

4. Hypersensitivity pneumonitis

5. Radiation pneumonitis

6. Pneumoconiosis

7. Post-COVID-19 pulmonary fibrosis

Patients with fibrotic lung lesion confirmed by HRCT performed within 6 months. Patients
who are scheduled to undergo tissue biopsy or surgery of the lung. Patients are ≥ 18 years
old at the time of the radiotracer administration. Patient can provide written informed
consent.

Exclusion Criteria:

Patient is pregnant or nursing. Patients with active infectious lung disease. Patients not
expected to comply with the protocol requirements, not able to understand or follow trial
procedures