RecruitingPhase 2NCT06940427

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

Sponsor

University of Wisconsin, Madison

Enrollment

50 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Fibrosis Lung

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

Min Age: 18 Years

Inclusion Criteria10

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 Criteria4

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

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