Fibrosis LungPhase 2NCT06940427
Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
A Phase 2 study testing FAPI tracer and PET/MRI in people with Fibrosis Lung, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis Lung
- What is being tested?
- FAPI tracer and PET/MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Stephanie Wilson, SWilson8@uwhealth.org
Ali Pirasteh, MD
About this study
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.
Read the detailed description
Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.
- Conditions
- Fibrosis Lung
- Being tested
- FAPI tracer, PET/MRI
- Keywords
- lung disease associated with fibrosis
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI tracerDrug
radioactive substance called a "tracer" injected into the arm
PET/MRIDevice
positron emission tomography (PET) takes pictures of inside of the body
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: FAPI tracer; Device: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start19 Nov 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis LungStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Pirasteh, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940427
- Sponsor's protocol ID
- 2025-0489
- Other IDs
- A539300, SMPH/RADIOLOGY/RADIOLOGY, Protocol Version 2/5/26
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
- ClinicalTrials.gov ID
- NCT06940427
- Acronym / sponsor ID
- 2025-0489
- Conditions
- Fibrosis Lung
- Keywords
- lung disease associated with fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A - 3 scans | Experimental | Drug: FAPI tracer, Device: PET/MRIParticipants 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. |
| Group B - 2 scans | Experimental | Drug: FAPI tracer, Device: PET/MRIParticipants 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. |
| Group B Crossover | Experimental | Drug: FAPI tracer, Device: PET/MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI tracerradioactive substance called a "tracer" injected into the arm | Drug | Group A - 3 scans, Group B - 2 scans, Group B Crossover |
| PET/MRIpositron emission tomography (PET) takes pictures of inside of the body | Device | Group A - 3 scans, Group B - 2 scans, Group B Crossover |
Primary outcome
Change in FAPI uptake
Time frame: Baseline to 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Fibrosis Lung
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Pirasteh, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAPI tracer and PET/MRI in people with Fibrosis Lung, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Studies (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FAPI uptake (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.