Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478255
Recruitment Status : Suspended (COVID-19)
First Posted : June 23, 2015
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

Brief Summary:

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other special types of MRI such as conventional proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate goal is to predict the degree of radiation-induced lung injury that will develop in a given patient for a given treatment plan. The investigators anticipate that these images will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. Investigational means that these tests have not yet been approved by the US Food and Drug Administration and are only available in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring changes due to thoracic radiation therapy, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because to develop a database of functional images that are representative of healthy lungs.


Condition or disease Intervention/treatment Phase
Radiation Injury Drug: Hyperpolarized 129-Xenon gas Device: MRI Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arm Intervention/treatment
Active Comparator: Patients scheduled to undergo Radiation Therapy (RT)
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Drug: Hyperpolarized 129-Xenon gas
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Other Name: Hyperpolarized 129Xe

Device: MRI
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

Active Comparator: Healthy volunteers Drug: Hyperpolarized 129-Xenon gas
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Other Name: Hyperpolarized 129Xe

Device: MRI
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.




Primary Outcome Measures :
  1. Change in pulmonary function, as measured by ventilation defect percentage (VDP) [ Time Frame: Baseline, following RT (up to 12 weeks) ]

Secondary Outcome Measures :
  1. Change in gas exchange defect percentage (EDP) following RT [ Time Frame: Baseline, following RT (up to 12 weeks) ]
    129Xe gas transfer from airspaces to pulmonary blood will be imaged 3 dimensionally. Regions where 129Xe does not transfer to blood are gas exchange defects. Those will be reported by their volume as a fraction of thoracic cavity volume

  2. Change in perfusion defect percentage (PDP) following RT [ Time Frame: Baseline, following RT (up to 12 weeks) ]
  3. RBC:barrier ratio [ Time Frame: Baseline, following RT (up to 12 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478255


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Bastiaan Driehuys
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Joseph Mammarappallil, M.D. Duke University
Layout table for additonal information
Responsible Party: Bastiaan Driehuys, Associate Professor of Radiology, Duke University
ClinicalTrials.gov Identifier: NCT02478255    
Other Study ID Numbers: Pro00059856
1R01HL105643-01 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Keywords provided by Bastiaan Driehuys, Duke University:
Radiation induced lung injury
Xenon gas
hyperpolarized
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiation Injuries
Wounds and Injuries
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs