Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04362644

3109239 (Other Grant/Funding Number)

R20-010

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

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

Experimental group

Treatment:

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