Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)

Description

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.

Official Title

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

Details

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. OUTLINE: 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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

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.

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

Location

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

Lead Scientist at University of California Health

  • Jeremie Calais (ucla)
    HS Associate Clinical Professor, Molecular and Medical Pharmacology, Medicine. Authored (or co-authored) 93 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05365802
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated