Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
NCT ID: NCT06940427
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-11-19
2027-09-30
Brief Summary
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Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group A - 3 scans
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.
FAPI tracer
radioactive substance called a "tracer" injected into the arm
PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Group B - 2 scans
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.
FAPI tracer
radioactive substance called a "tracer" injected into the arm
PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Group B Crossover
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.
FAPI tracer
radioactive substance called a "tracer" injected into the arm
PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Interventions
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FAPI tracer
radioactive substance called a "tracer" injected into the arm
PET/MRI
positron emission tomography (PET) takes pictures of inside of the body
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Ali Pirasteh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A539300
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/RADIOLOGY/RADIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 3/27/25
Identifier Type: OTHER
Identifier Source: secondary_id
2025-0489
Identifier Type: -
Identifier Source: org_study_id
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