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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Stephanie Lira
StephanieLira@mednet.ucla.edu
3102067372
Backup
Contreras M Maria, BS
MMContreras@mednet.ucla.edu
3102067372
Time Frame
Start Date: 2021-11-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: 68Ga-FAPi-46
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov