Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see if imaging with [18F]FDG and [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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

1. Age between 40-85 years old.

2. A diagnosis of IPF that fulfills ATS/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 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