Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04362644
• Other study ID #: R20-010
• Status: Recruiting
• Phase: Phase 1
• Start date: December 8, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: Jonathan McConathy, MD, PhD
• Phone: 205-996-7115
• Email: jmcconathy[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.