FAPI PET for Lung Fibrosis

Interstitial Lung Disease Clinical Trial

— FAPI ILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365802
• Other study ID #: IRB21-000678
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 16, 2021
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: Hamzah Alam, BS
• Phone: 3102067372
• Email: HAlam[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Fibrosis
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Idiopathic Interstitial Pneumonias
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pneumoconiosis
• Pneumonia
• Pulmonary Fibrosis
• Radiation Pneumonitis

Intervention

Drug:
• 68Ga-FAPi-46
Radiopharmaceutical will be administered via IV

Procedure:
• Computed Tomography
As part of PET/CT scan
• Positron Emission Tomography
As part of PET/CT scan
• High Resolution Computed Tomography
Will be conducted immediately after FAPI PET/CT

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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