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

Phase 2

Not yet recruiting

• Conditions: Fibrosis Lung
• Interventions: Drug: FAPI tracer; Device: PET/MRI

• Registration Number: NCT06940427
• Lead Sponsor: University of Wisconsin, Madison

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.

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 Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-23
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-09-29
• Study Start: 2025-11-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - 3 scans	FAPI tracer	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.
Group A - 3 scans	PET/MRI	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.
Group B - 2 scans	FAPI tracer	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.
Group B - 2 scans	PET/MRI	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.
Group B Crossover	FAPI tracer	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.
Group B Crossover	PET/MRI	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.

Primary Outcome Measures

Name	Time	Method
Change in FAPI uptake	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.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States