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

University of Wisconsin (UW)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Fibrosis Lung

Treatments: Drug: FAPI tracer; Device: PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06940427

2025-0489

SMPH/RADIOLOGY/RADIOLOGY (Other Identifier)

Protocol Version 3/27/25 (Other Identifier)

A539300 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older

• Able and willing to provide informed consent

• 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.

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Group A - 3 scans

Experimental group

Description:

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.

Treatment:

Device: PET/MRI

Drug: FAPI tracer

Group B - 2 scans

Experimental group

Description:

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.

Treatment:

Device: PET/MRI

Drug: FAPI tracer

Group B Crossover

Experimental group

Description:

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.

Treatment:

Device: PET/MRI

Drug: FAPI tracer