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

NCT06940427 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 4 other identifiers: 2025-0489A539300SMPH/RADIOLOGY/RADIOLOGYProtocol Version 2/5/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

lung disease associated with fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in FAPI uptake

  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.

  Baseline to 6 months

Study Arms (3)

Group A - 3 scans

EXPERIMENTAL

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.

Drug: FAPI tracer; Device: PET/MRI

Group B - 2 scans

EXPERIMENTAL

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.

Drug: FAPI tracer; Device: PET/MRI

Group B Crossover

EXPERIMENTAL

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.

Drug: FAPI tracer; Device: PET/MRI

Interventions

FAPI tracer DRUG

radioactive substance called a "tracer" injected into the arm

Group A - 3 scans; Group B - 2 scans; Group B Crossover

PET/MRI DEVICE

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

Group A - 3 scans; Group B - 2 scans; Group B Crossover

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Pirasteh, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups A and B will be parallel; however, Group B participants will have the option to crossover to Group A upon completing Group B participation.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 23, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)