FAPI PET/MRI for non-invasive measurement of lung fibrogenesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.