Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
ConditionFibrosis Lung
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
FAPI tracer
Drugradioactive substance called a "tracer" injected into the arm
PET/MRI
Devicepositron emission tomography (PET) takes pictures of inside of the body
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Group A - 3 scansExperimental treatment 2 interventions
Group B: Group B - 2 scansExperimental treatment 2 interventions
Group C: Group B CrossoverExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov