Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
NCT ID: NCT04362644
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2020-12-08
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET/CT using PET ligands [18F]FDG and [18F]DPA-714
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
85 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Jonathan E McConathy
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3109239
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R20-010
Identifier Type: -
Identifier Source: org_study_id
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