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

March 9, 2026 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 scarring) in the lungs.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin - Madison
        • Principal Investigator:
          • Ali Pirasteh, MD
        • Contact:
        • Sub-Investigator:
          • Julius Heidenreich, MD
        • Sub-Investigator:
          • Nathan Sandbo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.
  • Group B: Clinically evaluated and stable without need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, nor addition of new treatment (to any current treatment) in the setting of 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 follow up to have 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 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 research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR < 30 ml/min/1.73 m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - 3 scans
Participants undergo three PET/MRI scans using the FAPI radiotracer. They will have 3 research visits, and each visit may last up to 2.5 hours.
Drug: FAPI tracer
radioactive substance called a "tracer" injected into the arm
Device: PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Experimental: Group B - 2 scans
Participants undergo two PET/MRI scans using the FAPI radiotracer. They will have 2 research visits, and each visit may last up to 2.5 hours.
Drug: FAPI tracer
radioactive substance called a "tracer" injected into the arm
Device: PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Experimental: Group B Crossover
Participants undergo two additional PET/MRI scans using the FAPI radiotracer. They will have 2 additional research visits, and each visit may last up to 2.5 hours.
Drug: FAPI tracer
radioactive substance called a "tracer" injected into the arm
Device: PET/MRI
positron emission tomography (PET) takes pictures of inside of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FAPI uptake
Time Frame: Baseline to 6 months
FAPI uptake of fibrotic lesions as measured by Standardized Uptake Value (SUV). SUV quantifies the tracer uptake, helping to differentiate between normal and abnormal tissues and assess the extent of tumor activity.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ali Pirasteh, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0489
  • A539300 (Other Identifier: UW Madison)
  • SMPH/RADIOLOGY/RADIOLOGY (Other Identifier: UW Madison)
  • Protocol Version 2/5/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibrosis Lung

Clinical Trials on FAPI tracer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe