Status:
RECRUITING
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04362644
Start Date
December 8 2020
End Date
June 1 2027
Last Update
July 14 2025
Active Locations (1)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249