PET/CT Imaging for Idiopathic Pulmonary Fibrosis

Overseen By Jonathan McConathy, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Prednisone, Immunosuppressants

Disqualifiers: Diabetes, Infection, Cardiovascular disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of imaging scan can reveal lung inflammation and scarring in individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes breathing problems. The study will use PET/CT scans with specific markers ([18F]FDG and [18F]DPA-714) to enhance doctors' understanding of the condition. This could lead to improved treatments for IPF in the future. Candidates may qualify if diagnosed with IPF within the past five years and have no history of diabetes or recent lung infections. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this innovative approach.

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 prior data suggests that this imaging technique is safe for patients with idiopathic pulmonary fibrosis?

Research has shown that the PET imaging agents [F-18]FDG and [F-18]DPA-714 have been studied for safety and effectiveness. [F-18]FDG is often used in medical imaging to assess the severity of idiopathic pulmonary fibrosis (IPF), indicating its general safety and prior use in humans.

For [F-18]DPA-714, research indicates it targets proteins involved in inflammation. Although specific safety data for [F-18]DPA-714 in IPF patients is not detailed, its use in other studies suggests it can be safely used in human imaging.

As this trial is in the early stages, it primarily focuses on safety. So far, studies have not reported serious side effects for these imaging agents, suggesting they should be safe for human use. However, it is important to follow trial guidelines and report any issues to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/CT imaging with PET ligands [F-18]FDG and [F-18]DPA-714 for idiopathic pulmonary fibrosis (IPF) because it provides a new way to assess the disease. Unlike current treatments that focus on managing symptoms or slowing disease progression, this imaging technique targets the inflammation and fibrosis in the lungs at a molecular level. This method could allow doctors to see more precisely how the disease is affecting the lungs, potentially leading to earlier and more targeted treatment interventions. By visualizing active disease processes directly, it might even help in evaluating the effectiveness of treatments much earlier than traditional methods.

What evidence suggests that PET/CT imaging is effective for detecting lung inflammation and fibrosis in idiopathic pulmonary fibrosis?

This trial will use PET/CT scans with both [F-18]FDG and [F-18]DPA-714 to study idiopathic pulmonary fibrosis (IPF). Research has shown that PET/CT scans with [F-18]FDG can assess the severity of IPF and predict patient outcomes, with lower levels of [F-18]FDG linked to a better prognosis. Meanwhile, [F-18]DPA-714 effectively detects a protein related to inflammation, often elevated in diseases involving inflammation and tissue damage. These PET scans provide crucial images that enhance understanding of lung inflammation and scarring in IPF, potentially aiding doctors in developing better treatments for IPF in the future. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PET ligands [F-18]FDG and [F-18]DPA-714

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04362644

Molecular Imaging Probes to Inform Heterogeneity in ... Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests. screening to 48 hours post 2nd imaging ...

2. withpower.com withpower.com/trial/phase-1-idiopathic-pulmonary-fibrosis-11-2020-0f6e7

PET/CT Imaging 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12336105/

Emerging PET-radiotracers in cardiovascular, neuro ... Studies using [18F]DPA-714 and [11C]PBR28 have shown correlations between elevated TSPO signal and disease progression or cognitive decline, ...

4. ppmi-info.org ppmi-info.org/sites/default/files/docs/PPMI%20019%20DPA-714%20PET%20Imaging%20Study%20Protocol%20v1.1_27_Sep2023.pdf

Longitudinal TSPO PET imaging with [18F]DPA-714 in ... [18F]DPA-714, a 18Fluorine-labelled tracer, is proposed for this study due to its demonstrated high affinity for Translocator protein (TSPO) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25537727/

In vivo imaging and characterization of [(18)F]DPA-714, a ... These results suggest that [(18)F]DPA-714 is a suitable PET ligand for imaging in mice brain and peripheral tissues since it binds with high specificity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8760190/

Direct Comparison of [18F]F-DPA with [18F]DPA-714 and ... In this study we compared the recently developed TSPO tracer [18F]F-DPA, with [18F]DPA-714 and [11C]PBR28 by performing in vivo PET imaging on the same ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10502894/

a [18F]DPA-714 positron emission tomography study - PMC This observational study aimed to determine whether individuals with fibromyalgia (FM) exhibit higher levels of neuroinflammation than healthy controls (HCs).