Status:

RECRUITING

Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis

Lead Sponsor:

University of Wisconsin, Madison

Conditions:

Fibrosis Lung

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information c...

Detailed Description

Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarrin...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
  • Willing and able to undergo PET/MRI.
  • Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
  • The subject has their own prescription for the medication
  • Informed consent is obtained prior to the self-administration of this medication
  • They come to the research visit with a driver

Exclusion

  • Participant is unable or unwilling to provide informed consent
  • Participant is pregnant
  • Participant with contraindication(s) to or inability to undergo PET/MRI
  • Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2

Key Trial Info

Start Date :

November 19 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06940427

Start Date

November 19 2025

End Date

September 1 2027

Last Update

November 21 2025

Active Locations (1)

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University of Wisconsin - Madison

Madison, Wisconsin, United States, 53705