Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Overview

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

  • 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

Interventions

  • 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

Primary 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

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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, jmcconathy@uabmc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.