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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 October 2024 |
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Main ID: |
NCT04362644 |
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Date of registration:
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02/03/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
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Scientific title:
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Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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December 8, 2020 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04362644 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Jonathan McConathy, MD, PhD |
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Address:
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Telephone:
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205-996-7115 |
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Email:
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jmcconathy@uabmc.edu |
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Affiliation:
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Name:
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April Riddle, BSRT |
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Address:
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Telephone:
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205-934-6504 |
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Email:
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ariddle@uabmc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714
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Primary Outcome(s)
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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.]
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Secondary ID(s)
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3109239
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R20-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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