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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: June 1, 2022
- Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714
- Study participants will undergo PET/CT with the glucose analogue [F-18]FDG and the TSPO ligand [F-18]DPA-714 in two separate imaging sessions.
Arms, Groups and Cohorts
- Experimental: PET/CT using PET ligands [18F]FDG and [18F]DPA-714
Clinical Trial Outcome Measures
- Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
- Time Frame: screening to 48 hours post 2nd imaging visit.
Participating in This Clinical Trial
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.
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
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Alabama at Birmingham
- Provider of Information About this Clinical Study
- Principal Investigator: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics – University of Alabama at Birmingham
- Overall Contact(s)
- Jonathan McConathy, MD, PhD, 205-996-7115, firstname.lastname@example.org
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