Clinical Trial · NCT05365802

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

Overview

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.

Sponsor

Jonsson Comprehensive Cancer Center (UCLA)

Phase

Early Phase 1

Contacts

Hamzah Alam (Clinical Research Coordinator)

halam@mednet.ucla.edu

3102067372

Maria Contreras (Clinical Research Coordinator)

mmcontreras@mednet.ucla.edu

310-825-7336

ClinicalTrials.gov

NCT05365802

Eligibility

Inclusion

  • Patient can provide written informed consent
  • Patients who have/will initiate a new ILD med with 3 months of enrollment OR scheduled for a biopsy/surgery of the lung
  • Patients with ILD confirmed by CT at time of staging
  • Patients are ≥ 18 years old at the time of the radiotracer administration

Exclusion

  • Patients with active infectious lung disease
  • Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures
  • Patient is pregnant or nursing

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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