Using imaging to understand lung inflammation in pulmonary fibrosis

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

This study is testing new imaging techniques to see if they can help doctors better understand lung inflammation in people with idiopathic pulmonary fibrosis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04362644 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of molecular imaging probes, specifically fluorine-18 Fluorodeoxyglucose and fluorine-18 Displacement Per Atom, in detecting lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). By utilizing positron emission tomography and computed tomography (PET/CT), the study seeks to provide insights into the heterogeneity of IPF, which may inform future treatment strategies. Participants will undergo imaging to assess their condition, contributing to a better understanding of IPF.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-85 with a recent diagnosis of idiopathic pulmonary fibrosis meeting specific clinical criteria.

Not a fit: Patients experiencing acute exacerbations of IPF or those with certain comorbidities, such as diabetes or recent infections, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment approaches for patients with idiopathic pulmonary fibrosis.

How similar studies have performed: While the use of imaging in pulmonary fibrosis is explored, this specific approach using these particular probes is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age between 40-85 years old.
2. A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
3. Ability and willingness to give informed consent and adhere to study requirements.
4. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.70.
5. High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.

Exclusion Criteria:

1. Acute exacerbation of IPF within \<30 days
2. Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
3. Diagnoses of current infection by clinical or microbial assessments.
4. Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant.
5. Subjects with prior radiation therapy to the thorax.
6. Women who are pregnant, or who are breastfeeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
7. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke.
8. Subjects with known liver disease.
9. Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.
10. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
11. Active cigarette smoking or vaping

Where this trial is running

Birmingham, Alabama

• The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Study coordinator: Jonathan McConathy, MD, PhD

Conditions Idiopathic Pulmonary Fibrosis