FAPI PET for Lung Fibrosis

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.

Conditions

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

Interventions

DRUG

68Ga-FAPi-46

Radiopharmaceutical will be administered via IV

PROCEDURE

Computed Tomography

As part of PET/CT scan

PROCEDURE

Positron Emission Tomography

As part of PET/CT scan

PROCEDURE

High Resolution Computed Tomography

Will be conducted immediately after FAPI PET/CT

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Jeremie Calais, MD · Clinical Research Director, Ahmanson Translational Theranostics

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-16

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations