FAPI PET for Lung Fibrosis

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05365802
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Drug-Induced Pneumonitis
  • Hypersensitivity Pneumonitis
  • Idiopathic Interstitial Pneumonias
  • Interstitial Lung Disease
  • Pneumoconiosis
  • Pulmonary Fibrosis
  • Radiation Pneumonitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-FAPi-46 — DRUG
    Radiopharmaceutical will be administered via IV
  • Computed Tomography — PROCEDURE
    As part of PET/CT scan
  • Positron Emission Tomography — PROCEDURE
    As part of PET/CT scan
  • High Resolution Computed Tomography — PROCEDURE
    Will be conducted immediately after FAPI PET/CT

Study Details

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.

Key Dates

Start date
Nov 16, 2021
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-FAPi-46
    Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes

Primary Outcome Measure

To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease [ Time Frame: 60 minutes following injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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