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

Pneumoconiosis Radiation Pneumonitis Interstitial Lung Disease Pulmonary Fibrosis Hypersensitivity Pneumonitis Idiopathic Interstitial Pneumonias Drug-Induced Pneumonitis

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

Inclusion Criteria4

Patients with ILD confirmed by CT at time of staging
Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR 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 Criteria3

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

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