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FAPI PET for Lung Fibrosis (FAPI ILD)

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ClinicalTrials.gov Identifier: NCT05365802
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : May 12, 2022
Information provided by (Responsible Party):
Jeremie Calais, 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 with fibrotic lesions who are scheduled to undergo lung biopsy or transplantation.

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.

The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Idiopathic Interstitial Pneumonias Drug-Induced Pneumonitis Hypersensitivity Pneumonitis Radiation Pneumonitis Pneumoconiosis Pulmonary Fibrosis Drug: 68Ga-FAPi-46 Procedure: Computed Tomography Procedure: Positron Emission Tomography Early Phase 1

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 who are scheduled for lung biopsy or transplantation.

The biodistribution will be validated by histopathology and immunohistochemistry from obtained lung tissue.


  1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT
  2. Patients will be followed until pathology is obtained during clinical care.
  3. Biodistribution results will be assessed comparing pathological findings and PET/CT results

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : December 2023

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 Name: Gallium-68-FAPi-46

Procedure: Computed Tomography
As part of PET/CT scan
Other Name: CT scan

Procedure: Positron Emission Tomography
As part of PET/CT scan
Other Name: PET scan

Primary Outcome Measures :
  1. To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease [ Time Frame: 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 :
  1. 68Ga-FAPi-46 accumulation [ Time Frame: Up to 2 years ]
    To correlate PET imaging signal with fibroblast activation protein (FAP) expression by immunohistochemistry (IHC). 68Ga-FAPi-46 SUVs will be correlated with FAP expression from surgically resected tissue. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with the following ILD:

  1. Idiopathic interstitial pneumonia
  2. Connective tissue disease related intestitial lung disease (CTD-ILD)
  3. Drug-induced pneumonitis
  4. Hypersensitivity pneumonitis
  5. Radiation pneumonitis
  6. Pneumoconiosis
  7. Post-COVID-19 pulmonary fibrosis

Patients with fibrotic lung lesion confirmed by HRCT performed within 6 months. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05365802

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Contact: Wesley R Armstrong, BS 3102067372 warmstrong@mednet.ucla.edu
Contact: Erin Y Shen, BS 3102067372 eyshen@mednet.ucla.edu

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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Jeremie Calais, MD Clinical Research Director, Ahmanson Translational Theranostics
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Responsible Party: Jeremie Calais, Clinical Research Director, Ahmanson Translational Theranostics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05365802    
Other Study ID Numbers: IRB21-000678
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jeremie Calais, University of California, Los Angeles:
interstitial lung disease
pulmonary fibrosis
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Radiation Pneumonitis
Alveolitis, Extrinsic Allergic
Idiopathic Interstitial Pneumonias
Hamman-Rich Syndrome
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases
Lung Injury
Radiation Injuries
Wounds and Injuries
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Occupational Diseases
Idiopathic Pulmonary Fibrosis
Molecular Mechanisms of Pharmacological Action