FAPI PET for Pulmonary Fibrosis

Overseen By Stephanie Wilson

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

Trial Summary

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.

What data supports the effectiveness of the treatment FAPI tracer for pulmonary fibrosis?

Research shows that FAPI tracers, used in imaging, have been promising in detecting fibrosis in various conditions, including pulmonary and renal fibrosis. They help visualize fibroblast activity, which is crucial in the progression of fibrosis, suggesting potential effectiveness in monitoring pulmonary fibrosis. ^{1 2 3 4 5}

Is FAPI PET safe for humans?

FAPI tracers, used in imaging for various conditions including cancer, have shown good safety profiles with no significant side effects reported in studies. They are generally well-tolerated in humans, with low uptake in normal organs and fast clearance from the body. ^{1 3 5 6 7}

How is FAPI PET different from other treatments for pulmonary fibrosis?

FAPI PET is unique because it uses a tracer that targets fibroblast activation protein (FAP), which is overexpressed in fibrotic tissues, allowing for precise imaging of disease activity in pulmonary fibrosis. Unlike traditional treatments, FAPI PET is primarily a diagnostic tool rather than a therapeutic intervention, providing detailed insights into the extent and activity of fibrosis. ^{1 5 6 8 9}

What is the purpose of 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.

Research Team

Ali Pirasteh, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[68 Ga]Ga-FAPI-46 PET for non-invasive detection of pulmonary fibrosis disease activity. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Head-to-Head Comparison of FDG and Radiolabeled FAPI PET: A Systematic Review of the Literature. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A clinical study on relationship between visualization of cardiac fibroblast activation protein activity by Al18F-NOTA-FAPI-04 positron emission tomography and cardiovascular disease. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

99mTc-Labeled FAPI SPECT Imaging in Idiopathic Pulmonary Fibrosis: Preliminary Results. [2023]

6. United States 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein Inhibitor (FAPI)-Based Theranostics-Where We Are at and Where We Are Heading: A Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

How to Perform FAPI PET? An Expedited Systematic Review Providing a Recommendation for FAPI PET Imaging With Different FAPI Tracers. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein-Specific PET/CT Imaging in Fibrotic Interstitial Lung Diseases and Lung Cancer: A Translational Exploratory Study. [2022]