FAPI PET for Pulmonary Fibrosis

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Severe kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new imaging agent, the FAPI tracer, interacts with lung tissue affected by fibrosis (a type of lung scarring). The goal is to enhance the diagnosis and monitoring of diseases like idiopathic pulmonary fibrosis (IPF) and hypersensitivity pneumonitis (HSP). Participants will undergo PET/MRI scans—some will have two, others three—to collect this crucial data. This trial may suit those recently evaluated for changes in their lung fibrosis treatment. Participants should be comfortable undergoing PET/MRI scans and not require IV sedation.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in diagnosing and monitoring lung fibrosis.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems you may continue your current treatment, but it's best to confirm with the trial coordinators.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that FAPI tracers are generally safe for people. Studies have found that these tracers are well-tolerated when used for PET scans, which help doctors see inside the body. Most FAPI research has focused on cancer and heart disease, with no major safety issues reported in these areas. This suggests that FAPI tracers are likely safe for scanning fibrotic lung tissue as well.

Since this trial is in an early stage, it primarily aims to understand how the FAPI tracer functions in the body. This usually indicates that the tracer has already demonstrated some level of safety in previous studies. Participants in this trial will undergo a few scans, but based on current knowledge, no severe side effects are expected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the FAPI PET technique for pulmonary fibrosis because it offers a new way to visualize and understand the disease. Unlike many current treatments that focus on managing symptoms or slowing disease progression, FAPI PET employs a novel radiotracer that targets fibroblast activation, providing detailed images of fibrotic activity in the lungs. This technique could help doctors pinpoint disease activity more accurately, potentially leading to more personalized and effective treatment strategies. By enhancing our understanding of disease mechanisms, FAPI PET could pave the way for innovative therapies and improved outcomes for patients with pulmonary fibrosis.

What evidence suggests that the FAPI tracer is effective for diagnosing and tracking pulmonary fibrosis?

Research has shown that FAPI tracers are promising tools for tracking lung scarring. These tracers attach to a specific protein found in scarred lung areas, aiding doctors in visualizing and measuring scarring through imaging techniques. In this trial, participants will undergo PET/MRI scans with the FAPI radiotracer to monitor lung scarring. In some cases, FAPI tracers successfully monitored changes in lung scarring during treatment. Overall, evidence supports using FAPI tracers to enhance understanding and tracking of lung scarring, potentially aiding in diagnosing and monitoring the condition over time. ^{1 6 7 8 9}

Who Is on the Research Team?

Ali Pirasteh, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with pulmonary fibrosis, a condition where lung tissue becomes scarred and thickened. Participants will undergo up to four PET/MRI scans using the FAPI tracer to help diagnose and monitor their condition.

Inclusion Criteria

Willing and able to undergo PET/MRI

Able and willing to provide informed consent

I need new or changed treatment for my lung condition.

Exclusion Criteria

Participant is pregnant

Participant with contraindication(s) to or inability to undergo PET/MRI

I cannot or do not want to give consent for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MRI scans using the FAPI radiotracer to assess fibrogenesis in the lungs

Up to 6 months

Up to 4 visits (in-person)

Follow-up

Participants are monitored for changes in FAPI uptake and fibrotic lesion activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FAPI tracer

Trial Overview

The study is testing how well a substance called FAPI can highlight areas of lung scarring when used with PET/MRI scanning technology. This could potentially improve diagnosis and tracking of fibrotic lung diseases.

How Is the Trial Designed?

Group I: Group B Crossover Experimental Treatment 2 Interventions

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.

Group II: Group B - 2 scans Experimental Treatment 2 Interventions

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.

Group III: Group A - 3 scans Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

The study evaluated two new PET tracers, 68Ga-FAPI-2 and 68Ga-FAPI-4, in 50 cancer patients, showing that they provide similar or better tumor-to-background contrast compared to the standard 18F-FDG, with no need for dietary restrictions before the scan.

Both tracers demonstrated a low uptake in normal tissues and a rapid clearance via the kidneys, making them promising tools for cancer diagnostics with effective imaging capabilities shortly after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET/CT: Biodistribution and Preliminary Dosimetry Estimate of 2 DOTA-Containing FAP-Targeting Agents in Patients with Various Cancers. Giesel, FL., Kratochwil, C., Lindner, T., et al.[2021]

The study evaluated the safety and efficacy of a new imaging agent, 99mTc-HFAPI, in 11 patients with idiopathic pulmonary fibrosis (IPF), showing no side effects and normal physiological uptake in organs like the liver and pancreas.

99mTc-HFAPI imaging demonstrated elevated uptake in fibrotic lung regions, correlating significantly with disease severity on high-resolution CT scans and pulmonary function test results, suggesting its potential for monitoring disease progression in IPF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

99mTc-Labeled FAPI SPECT Imaging in Idiopathic Pulmonary Fibrosis: Preliminary Results. Liu, Y., Zhang, Q., Zhang, Y., et al.[2023]

FAPI PET imaging using [68Ga]Ga-FAPI-46 was able to detect increased lung uptake in a mouse model of pulmonary fibrosis at both 7 and 14 days post-bleomycin administration, indicating its potential as a biomarker for disease activity.

In contrast, traditional CT imaging only identified differences in fibrosis at 14 days, highlighting FAPI PET's superior ability to assess early disease activity and response to treatment in idiopathic pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68 Ga]Ga-FAPI-46 PET for non-invasive detection of pulmonary fibrosis disease activity. Rosenkrans, ZT., Massey, CF., Bernau, K., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11492823/

Fibroblast activation protein inhibitor PET/CT as an emerging ...

One of the studies on IPF cohorts using FDG-PET showed significant correlation of tracer uptake with increasing pulmonary fibrosis, functional ...

2.

nature.com

nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein inhibitor ...

This article summarizes the current state of clinical FAPI-PET imaging as well as potential uses as a theranostic agent.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1568997225001168

Radio-labelled fibroblast activation protein inhibitors in ...

This review examines the association between pulmonary FAPI tracer uptake, fibrotic activity, and clinical parameters used for disease monitoring and ...

4.

jnm.snmjournals.org

jnm.snmjournals.org/content/63/1/127

Fibroblast Activation Protein–Specific PET/CT Imaging in ...

Methods: PET scans of 15 patients with fILD and suspected LC were acquired 10, 60, and 180 min after the administration of 150–250 MBq of a 68Ga ...

5.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1613010/full

68Ga-FAPI PET/CT for diagnostic accuracy and therapeutic ...

Our research indicates that 68Ga-FAPI PET can accurately reflect the changes in nintedanib treatment before and after pulmonary fibrosis, with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12030087/

Fibroblast Activation Protein Inhibitor (FAPI)-Based Theranostics

This review highlights the expanding clinical applications of FAPI-based PET imaging across oncology, inflammation, and cardiovascular disease.

7.

pubs.rsna.org

pubs.rsna.org/doi/abs/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use ...

FAPI PET can be integrated in the clinical workflow and enables the detection of small primary or metastatic lesions, especially in the brain, liver, pancreas, ...

8.

jnm.snmjournals.org

jnm.snmjournals.org/content/jnumed/65/Supplement_1/4S.full-text.pdf

Fibroblast Activation Protein Inhibitor Tracers and Their ...

Lesion uptake using FAPI PET has also been positively correlated with disease stage or severity in patients with various conditions, such as renal fibrosis (58) ...

9.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1393778/full

The fibroblast activation protein alpha as a biomarker of ...

In this review, we discuss the use of FAPα as a useful biomarker for the progression of lung fibrosis, by both its assessment in human fluids and/or its ...