Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

University of Alabama at Birmingham1 site in 1 country10 target enrollmentDecember 8, 2020

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsPET/CT using PET ligands [F-18]FDG and [F-18]DPA-714

DrugsPET/CT using PET ligands [F-18]FDG and [F-18]DPA-714

Overview

Phase: Phase 1
Intervention: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: University of Alabama at Birmingham
Enrollment: 10
Locations: 1
Primary Endpoint: Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2020

End Date

June 1, 2027

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

•Age between 40-85 years old.
•A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
•Ability and willingness to give informed consent and adhere to study requirements.
•Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.
•High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.

Exclusion Criteria

•Acute exacerbation of IPF within \<30 days
•Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
•Diagnoses of current infection by clinical or microbial assessments.
•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.
•Subjects with prior radiation therapy to the thorax.
•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.
•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.
•Subjects with known liver disease.
•Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.
•Low affinity binder for TSPO ligands based on genotyping for SNP rs