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

Last updated: March 9, 2026
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

2

Condition

Cystic Fibrosis

Lung Injury

Lung Disease

Treatment

PET/MRI

FAPI tracer

Clinical Study ID

NCT06940427
2025-0489
Protocol Version 3/27/25
A539300
SMPH/RADIOLOGY/RADIOLOGY
Protocol Version 2/5/26
  • Ages > 18
  • All Genders

Study 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 can be used to better diagnose and track fibrotic lung disease activity.

Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Able and willing to provide informed consent

  • Group A: Clinically evaluated for need for initiation of new treatment (in patientsnot on current treatment), initiation of change in current treatment, or addition ofnew treatment (to any current treatment) in the setting of fibrotic hypersensitivitypneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinicalcare at UW Health.

  • Group B: Clinically evaluated and stable without need for initiation of newtreatment (in patients not on current treatment), initiation of change in currenttreatment, nor addition of new treatment (to any current treatment) in the settingof fibrotic hypersensitivity pneu-monitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.

  • Crossover (Group B to A): Enrolled in Group B and found at next SOC clinical followup to have need for initiation of new treatment (in patients not on currenttreatment), 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 UWHealth.

  • Willing and able to undergo PET/MRI.

  • Participants requiring intravenous (IV) conscious sedation for imaging are noteligible; participants requiring mild, oral anxiolytics for the clinical MRI will beallowed 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 thismedication

  • They come to the research visit with a driver

Exclusion

Exclusion Criteria:

  • 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 researchimaging without the use of contrast. Contraindications may be severe kidney diseaseor previously documented GFR < 30 ml/min/1.73 m2

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: PET/MRI
Phase: 2
Study Start date:
November 19, 2025
Estimated Completion Date:
September 30, 2027

Study 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 scarring) in the lungs.

Connect with a study center

  • University of Wisconsin - Madison

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • University of Wisconsin - Madison

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Site Not Available

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