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Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.

Secondary Outcome Measures

Full Information

NCT ID

NCT04362644

First Posted

March 2, 2020

Last Updated

June 29, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT04362644

Brief Title

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Official Title

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 8, 2020 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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) >0.70. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan McConathy, MD, PhD

Phone

205-996-7115

jmcconathy@uabmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

April Riddle, BSRT

Phone

205-934-6504

ariddle@uabmc.edu

Facility Information:

Facility Name

The University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

April Riddle, BSRT

Phone

205-934-6504

ariddle@uabmc.edu

12. IPD Sharing Statement

Learn more about this trial

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

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