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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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14 March 2022 |
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Main ID: |
NCT02478255 |
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Date of registration:
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16/06/2015 |
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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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Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
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Scientific title:
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Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment |
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Date of first enrolment:
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March 21, 2016 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02478255 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 2
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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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Joseph Mammarappallil, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria for Patients:
1. Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20
Gy
2. Willing and able to give informed consent and adhere to visit/protocol schedules
Exclusion Criteria for Patients:
1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI Screening questionnaire
3. Subject is pregnant or lactating
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has any form of known cardiac arrhythmia
6. Subject does not fit into 129Xe vest coil used for MRI
7. Subject cannot hold his/her breath for 15 seconds
8. Subject deemed unlikely to be able to comply with instructions during imaging
9. Medical or psychological conditions which, in the opinion of the investigator, might
create undue risk to the subject or interfere with the subject's ability to comply
with the protocol requirements
Inclusion/Exclusion Criteria for Healthy Volunteers
1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory
disease.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Radiation Injury
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Intervention(s)
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Device: MRI
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Drug: Hyperpolarized 129-Xenon gas
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Primary Outcome(s)
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Change in pulmonary function, as measured by ventilation defect percentage (VDP)
[Time Frame: Baseline, following RT (up to 12 weeks)]
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Secondary Outcome(s)
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Change in gas exchange defect percentage (EDP) following RT
[Time Frame: Baseline, following RT (up to 12 weeks)]
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Change in perfusion defect percentage (PDP) following RT
[Time Frame: Baseline, following RT (up to 12 weeks)]
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RBC:barrier ratio
[Time Frame: Baseline, following RT (up to 12 weeks)]
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Secondary ID(s)
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1R01HL105643-01
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Pro00059856
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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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