Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06940427

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Ali Pirasteh, MD

PRINCIPAL_INVESTIGATOR

Julius Heidenreich, MD

SUB_INVESTIGATOR

Nathan Sandbo, MD

SUB_INVESTIGATOR

Stephanie Wilson

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAPI tracer

Drug

radioactive substance called a "tracer" injected into the arm

PET/MRI

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Radiology Studies

CONTACT

[email protected]

608-282-8349

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.