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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PET/CT using PET ligands [18F]FDG and [18F]DPA-714
  • 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 translocator protein (TSPO) ligand [F-18]DPA-714 in two separate imaging sessions.

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
April Riddle, BSRT
205-934-6504
ariddle@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.