Using a new imaging technique to assess lung fibrosis
PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.
EARLY_PHASE1 · University of California, Los Angeles · NCT05365802
This study is testing a new imaging technique to see how a special tracer behaves in the lungs of people with interstitial lung disease to help improve treatment and understanding of their condition.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05365802 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to evaluate the biodistribution of the FAPI tracer (68Ga-FAPi-46) in patients diagnosed with interstitial lung disease (ILD). Participants will receive the tracer and undergo PET/CT and high-resolution CT scans to determine how the tracer accumulates in both normal and fibrotic lung tissues. The study will include 30 patients who are either starting a new ILD medication or are scheduled for lung biopsy or surgery. The goal is to improve prognostication and treatment strategies for patients with fibrosing ILD by better understanding the disease's progression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed interstitial lung disease who are starting a new medication or undergoing lung surgery.
Not a fit: Patients who are pregnant, nursing, or have active infectious lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for patients with interstitial lung disease.
How similar studies have performed: While this approach is novel in the context of ILD, similar imaging techniques have shown promise in other fibrotic diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Jeremie Calais, MD — Clinical Research Director, Ahmanson Translational Theranostics
- Study coordinator: Stephanie Lira
- Email: StephanieLira@mednet.ucla.edu
- Phone: 3102067372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis, Hypersensitivity Pneumonitis, Radiation Pneumonitis, Pneumoconiosis, Pulmonary Fibrosis, interstitial lung disease