Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT04362644

Collaborator

(none)

Enrollment

Location

Arm

29.7

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Actual Study Start Date :

Dec 8, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

0.70.

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 rs6971.
Active cigarette smoking or vaping

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04362644

Other Study ID Numbers:

R20-010

First Posted:

Apr 27, 2020

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Fibrosis

Study Results

No Results Posted as of Jun 9, 2022