FAPI PET for Lung Fibrosis

Early Phase 1

Recruiting

• Conditions: Radiation Pneumonitis; Interstitial Lung Disease; Idiopathic Interstitial Pneumonias; Drug-Induced Pneumonitis; Pulmonary Fibrosis; Hypersensitivity Pneumonitis; Pneumoconiosis
• Interventions: Drug: 68Ga-FAPi-46; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: High Resolution Computed Tomography

• Registration Number: NCT05365802
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

ILD is a group of respiratory diseases that affect the interstitium of the lungs. A major problem is the highly variable course of fibrosing ILD: some patients remain stable without treatment, and others progress rapidly despite pharmacotherapy.

Novel diagnostic approaches for risk stratification with more accurate prediction of the course of fibrosing ILD could potentially improve prognostication and ultimately lead to better survival in these patients.

Persistent activation and local accumulation of myofibroblasts is a common feature of fibrotic diseases. FAP is a promising target for molecular imaging of fibroblast activation and detection of sites of active tissue remodeling.

Small molecule inhibitors of FAP have been labeled with positron-emitting isotopes for PET imaging. 68Ga-FAPi-46 can serve as diagnostic biomarker in ILD.

In this study, the investigators will evaluate the 68Ga-FAPi-46 biodistribution in patients with ILD and observe the correlation of FAP expression and FAPi radiopharmaceutical uptake.

The primary objective of this study is to evaluate the biodistribution of the new FAP-targeted PET tracer, 68Ga-FAPi- 46, in patients with ILD.

OUTLINE:

1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs

2. Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)

3. Biodistribution results will be assessed comparing pathological findings and PET/CT results

Study Timeline

• Study Start: 2021-11-16
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPi-46	68Ga-FAPi-46	Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
68Ga-FAPi-46	Computed Tomography	Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
68Ga-FAPi-46	Positron Emission Tomography	Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
68Ga-FAPi-46	High Resolution Computed Tomography	Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes

Primary Outcome Measures

Name	Time	Method
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease	60 minutes following injection	To quantify diseased tissue and normal background organs, 68Ga-FAPI-46 positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).

Secondary Outcome Measures

Name	Time	Method
68Ga-FAPi-46 accumulation	Up to 2 years	To evaluate the degree of 68Ga-FAPi-46 accumulation observed by PET imaging as opposed to the amount of FAP expression in obtained lung tissue, when available. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
68Ga-FAPi-46 biodistribution	Up to 2 years	To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters
68Ga-FAPi-46 and disease progression	Up to 2 years	To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States