FAPI PET for Lung Fibrosis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 68Ga-FAPi-46
  • Computed Tomography
  • Positron Emission Tomography
  • High Resolution Computed Tomography

Treatment groups

30 Participants
are divided into 1 treatment group