Recruiting
Phase 2

FAPI

Sponsor:

University of Wisconsin, Madison

Code:

NCT06940427

Conditions

Fibrosis Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAPI tracer

PET/MRI

Study Details

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 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.

Conditions

Fibrosis Lung

Study ID

NCT06940427

Start date

Nov 19, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

FAPI tracer

radioactive substance called a "tracer" injected into the arm

PET/MRI

positron emission tomography (PET) takes pictures of inside of the body

Primary outcome measure

  • Change in FAPI uptake [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349Radstudy@uwhealth.org

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Stephanie Wilson

SWilson8@uwhealth.org

Principal Investigator:

Ali Pirasteh, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • lung disease associated with fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-11.