for people ages 18 years and up (full criteria)
at Los Angeles, California
study started
completion around
Principal Investigator
by Jeremie Calais
Headshot of Jeremie Calais
Jeremie Calais



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.

Official Title

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


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.


  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


Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis, Hypersensitivity Pneumonitis, Radiation Pneumonitis, Pneumoconiosis, Pulmonary Fibrosis, 68Ga-FAPi-46, Pneumonia, Lung Diseases, Interstitial Lung Diseases, Extrinsic Allergic Alveolitis, Hamman-Rich Syndrome, Hypersensitivity, Fibrosis, FAPI-46, Computed Tomography, Positron Emission Tomography, High Resolution Computed Tomography


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Jeremie Calais
    Nuclear medicine physician specialized in cancer imaging and theranostics. Associate Professor, Department of Molecular and Medical Pharmacology at UCLA Director, Theranostics Program, Ahmanson Translational Theranostics Division at UCLA Faculty Member of the Jonsson Comprehensive Cancer Center at UCLA. Faculty Member of the Institute of Urologic Oncology at UCLA.


accepting new patients
Start Date
Completion Date
University of California, Los Angeles
Sign up for this study
Phase 1 research study
Study Type
Expecting 30 study participants
Last Updated