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NCT Number: NCT04362644

Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis

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.

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location status: Recruiting

Location contact

April Riddle, BSRT

CONTACT

[email protected]

205-934-6504

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

April Riddle, BSRT

CONTACT

[email protected]

205-934-6504

Jonathan McConathy, MD, PhD

CONTACT

[email protected]

205-996-7115

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2020
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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