FAPI PET for Lung Fibrosis (FAPI ILD)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ethan C Lam, BS; Phone Number: 3102067372; Email: eclam@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-FAPi-46; Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes	Drug: 68Ga-FAPi-46; Radiopharmaceutical will be administered via IV; Other Names: Gallium-68-FAPi-46; Procedure: Computed Tomography; As part of PET/CT scan; Other Names: CT scan; Procedure: Positron Emission Tomography; As part of PET/CT scan; Other Names: PET scan; Procedure: High Resolution Computed Tomography; Will be conducted immediately after FAPI PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease	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)).	60 minutes following injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
68Ga-FAPi-46 accumulation	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.	Up to 2 years
68Ga-FAPi-46 and disease progression	To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.	Up to 2 years
68Ga-FAPi-46 biodistribution	To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters	Up to 2 years

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: interstitial lung disease; pulmonary fibrosis; 68Ga-FAPi-46
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Wounds and Injuries; Occupational Diseases; Respiratory Hypersensitivity; Lung Injury; Radiation Injuries; Idiopathic Pulmonary Fibrosis; Fibrosis; Hypersensitivity; Lung Diseases; Pneumonia; Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias; Hamman-Rich Syndrome; Pneumoconiosis; Radiation Pneumonitis; Alveolitis, Extrinsic Allergic; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46
• Other Study ID Numbers: IRB21-000678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes