FAPI PET for Lung Fibrosis

NCT05365802 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB21-000678
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

interstitial lung disease; pulmonary fibrosis; 68Ga-FAPi-46

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 68Ga-FAPi-46 accumulation

  Up to 2 years

• 68Ga-FAPi-46 and disease progression

  Up to 2 years

• 68Ga-FAPi-46 biodistribution

  Up to 2 years

Study Arms (1)

68Ga-FAPi-46

EXPERIMENTAL

Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes

Drug: 68Ga-FAPi-46; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: High Resolution Computed Tomography

Interventions

68Ga-FAPi-46 DRUG

Radiopharmaceutical will be administered via IV

Also known as: Gallium-68-FAPi-46

68Ga-FAPi-46

Computed Tomography PROCEDURE

As part of PET/CT scan

Also known as: CT scan

68Ga-FAPi-46

Positron Emission Tomography PROCEDURE

As part of PET/CT scan

Also known as: PET scan

68Ga-FAPi-46

High Resolution Computed Tomography PROCEDURE

Will be conducted immediately after FAPI PET/CT

68Ga-FAPi-46

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias; Alveolitis, Extrinsic Allergic; Radiation Pneumonitis; Pneumoconiosis; Pulmonary Fibrosis

Interventions

FAPI-46; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Idiopathic Pulmonary Fibrosis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries; Occupational Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeremie Calais, MD

  Clinical Research Director, Ahmanson Translational Theranostics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lira

CONTACT

3102067372; StephanieLira@mednet.ucla.edu

Contreras M Maria, BS

CONTACT

3102067372; MMContreras@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director, Ahmanson Translational Theranostics

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 9, 2022
• Study Start: November 16, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)