FAPI PET/MRI for non-invasive measurement of lung fibrogenesis
Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
This project will test whether FAPI PET/MRI scans can detect active scarring in adults with fibrotic lung diseases such as idiopathic pulmonary fibrosis or fibrotic hypersensitivity pneumonitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06940427 on ClinicalTrials.gov |
What this trial studies
Participants will receive a FAPI radiotracer and undergo up to four combined PET/MRI scans to image activated fibroblasts in lung tissue. Enrollees are categorized as Group A if they need a new or changed treatment and Group B if they are clinically stable, with some Group B participants able to cross over if their clinical care changes. Imaging uptake patterns will be compared with clinical status and treatment decisions to determine whether FAPI signal corresponds with ongoing fibrogenesis. The aim is to develop a non-invasive biomarker to help diagnose and track fibrotic lung disease activity.
Who should consider this trial
Good fit: Adults (18+) with idiopathic pulmonary fibrosis or fibrotic hypersensitivity pneumonitis who can undergo PET/MRI and are either facing a treatment initiation/change or are clinically stable are the intended participants.
Not a fit: People without fibrotic lung disease, those who cannot have PET/MRI (for example due to MRI contraindications or pregnancy), or patients whose management would not change based on imaging are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a non-invasive imaging biomarker to detect and monitor active lung scarring and help guide treatment decisions.
How similar studies have performed: FAPI PET has shown promising binding to activated fibroblasts in cancer and early fibrosis work, but using it specifically as a pulmonary fibrogenesis biomarker is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin - Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Ali Pirasteh, MD — University of Wisconsin, Madison
- Study coordinator: Radiology Studies
- Email: Radstudy@uwhealth.org
- Phone: 608-282-8349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.