PET/CT Imaging for Idiopathic Pulmonary Fibrosis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Prednisone, Immunosuppressants

Disqualifiers: Diabetes, Infection, Cardiovascular disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose (\[18F\] FDG) and fluorine-18 Displacement Per Atom (\[18F\]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have been treated with high doses of prednisone or any cellular immunosuppressant in the last month. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment PET ligands [F-18]FDG and [F-18]DPA-714 for idiopathic pulmonary fibrosis?

Research suggests that PET/CT imaging using [F-18]FDG can help assess disease severity and predict survival in idiopathic pulmonary fibrosis (IPF) patients, which may guide treatment decisions. ^{1 2 3 4 5}

How does PET/CT imaging differ from other treatments for idiopathic pulmonary fibrosis?

PET/CT imaging for idiopathic pulmonary fibrosis is unique because it uses a special type of scan to help predict disease progression and assess the severity of the condition, rather than directly treating it. This approach can identify active disease areas and guide treatment decisions, offering a new way to manage a disease with limited treatment options. ^{1 2 5 6 7}

Research Team

Eligibility Criteria

This trial is for adults aged 40-85 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) according to specific criteria, who can consent and follow study procedures. They must have certain lung function levels and genetic markers. Excluded are those with severe heart disease, liver disease, recent cancer (except skin), diabetes, recent IPF exacerbation or infection, high-dose steroid or immunosuppressant use in the last month, and current smokers/vapers.

Inclusion Criteria

I was diagnosed with IPF based on ATS/ERS criteria within the last 5 years.

I am between 40 and 85 years old.

Your breathing test shows a specific ratio of air you can force out in one second to the total amount you can force out.

Exclusion Criteria

My genetics show low binding for specific brain markers.

I have not had a heart attack, unstable angina, heart surgery, or stroke in the last 3 months.

I have an active cancer diagnosis, except for skin cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/CT imaging using [18F]FDG and [18F]DPA-714 to assess lung inflammation and fibrosis

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• PET ligands [F-18]FDG and [F-18]DPA-714 (Imaging Probe)

Trial Overview The trial tests if PET/CT scans using two imaging agents ([18F]FDG and [18F]DPA-714) can effectively show inflammation and fibrosis in the lungs of IPF patients. This could improve understanding of IPF's variability among patients and inform future treatment strategies.

Participant Groups

Group I: PET/CT using PET ligands [18F]FDG and [18F]DPA-714 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

In a study of 113 idiopathic pulmonary fibrosis (IPF) patients, a high pulmonary target-to-background ratio (TBR) from 18F-FDG-PET/CT scans was found to be independently associated with an increased risk of mortality, indicating its potential as a prognostic biomarker.

The study demonstrated that combining the TBR with the established GAP scoring system improved the prediction of mortality in IPF patients, suggesting that this 'PET modified GAP score' could enhance risk stratification for better patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary 18F-FDG uptake helps refine current risk stratification in idiopathic pulmonary fibrosis (IPF). Win, T., Screaton, NJ., Porter, JC., et al.[2018]

In a study of 89 patients with idiopathic pulmonary fibrosis (IPF), 18F-FDG PET/CT imaging showed that various standardized uptake values (SUV) were inversely correlated with lung function, indicating that higher SUV values may reflect more severe disease.

The SUV ratio (SUVR) was identified as a significant predictor of mortality in IPF patients, suggesting that 18F-FDG PET/CT could be a valuable tool for assessing disease severity and prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of 18F-FDG PET/CT in Evaluating Disease Severity and Prognosis in Idiopathic Pulmonary Fibrosis Patients. Yoon, HY., Lee, SH., Ha, S., et al.[2022]

In a study of 425 lung cancer patients, those with idiopathic interstitial pneumonia (IIP) and a higher 18F-FDG PET/CT SUVmax (≥ 2.55) had a significant risk of acute exacerbation after lung surgery, with a 33.3% 90-day mortality rate in this group.

The findings suggest that measuring SUVmax in the IIP area can help predict complications and short-term survival outcomes in lung cancer patients, indicating a need for closer monitoring and potential interventions for those with elevated SUVmax.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between preoperative 18F-FDG PET/CT findings and postoperative short-term prognosis in lung cancer patients with idiopathic interstitial pneumonia after lung resection. Oishi, H., Sakurada, A., Notsuda, H., et al.[2021]

In a study of 50 patients with idiopathic pulmonary fibrosis (IPF), a positive retention index value (RI-SUV) from dual-time-point (18)F-FDG PET imaging was found to be a strong predictor of shorter progression-free survival, with a median of 13.3 months compared to 27.9 months for those with negative RI-SUV.

The study also revealed that a positive RI-SUV is associated with significantly higher mortality rates, with a 5-year survival rate of only 14.3% for patients with positive RI-SUV compared to 76.8% for those with negative RI-SUV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic Value of Dual-Time-Point 18F-FDG PET for Idiopathic Pulmonary Fibrosis. Umeda, Y., Demura, Y., Morikawa, M., et al.[2016]

A new PET probe, 68GaPIF-7, was developed to specifically identify lung fibrogenesis in a pre-clinical model of idiopathic pulmonary fibrosis (IPF), showing high uptake in injured lung tissue compared to normal tissue and surrounding organs.

This probe has the potential to be translated into clinical use, providing a valuable tool for predicting disease progression and guiding treatment decisions in patients with IPF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of an Allysine-Targeted PET Probe for Quantifying Fibrogenesis in a Mouse Model of Pulmonary Fibrosis. Shuvaev, S., Knipe, RS., Drummond, M., et al.[2023]

Whole body positron emission tomography (PET) using F-18 FDG can help identify metabolically active areas in idiopathic pulmonary fibrosis (IPF), which may indicate regions that could respond to treatment.

The imaging technique revealed not only active disease in the lungs but also potential extrapulmonary involvement, highlighting the complexity of IPF and the need for comprehensive diagnostic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography in idiopathic pulmonary fibrosis: A new ray of hope! Desai, U., Karkhanis, VS., Basu, S., et al.[2020]

Hypoxia imaging using [18F]FMISO can serve as an early predictive biomarker for disease progression in idiopathic pulmonary fibrosis (IPF), showing changes before they are visible on traditional CT scans.

Both nintedanib and pirfenidone significantly reduced lung fibrosis and hypoxia markers, indicating their efficacy in treating IPF, with [18F]FMISO uptake correlating with the effectiveness of nintedanib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]FMISO PET/CT imaging of hypoxia as a non-invasive biomarker of disease progression and therapy efficacy in a preclinical model of pulmonary fibrosis: comparison with the [18F]FDG PET/CT approach. Tanguy, J., Goirand, F., Bouchard, A., et al.[2022]

References

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

Pulmonary 18F-FDG uptake helps refine current risk stratification in idiopathic pulmonary fibrosis (IPF). [2018]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The Value of 18F-FDG PET/CT in Evaluating Disease Severity and Prognosis in Idiopathic Pulmonary Fibrosis Patients. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Correlation between preoperative 18F-FDG PET/CT findings and postoperative short-term prognosis in lung cancer patients with idiopathic interstitial pneumonia after lung resection. [2021]

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

Prognostic Value of Dual-Time-Point 18F-FDG PET for Idiopathic Pulmonary Fibrosis. [2016]

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

Optimization of an Allysine-Targeted PET Probe for Quantifying Fibrogenesis in a Mouse Model of Pulmonary Fibrosis. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography in idiopathic pulmonary fibrosis: A new ray of hope! [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[18F]FMISO PET/CT imaging of hypoxia as a non-invasive biomarker of disease progression and therapy efficacy in a preclinical model of pulmonary fibrosis: comparison with the [18F]FDG PET/CT approach. [2022]