Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: April Riddle, BSRT; Phone Number: 205-934-6504; Email: ariddle@uabmc.edu
• Study Contact Backup: Name: Jonathan McConathy, MD, PhD; Phone Number: 205-996-7115; Email: jmcconathy@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • The University of Alabama at Birmingham
      • Contact: April Riddle, BSRT; Phone Number: 205-934-6504; Email: ariddle@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.	screening to 48 hours post 2nd imaging visit.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: R20-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No