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

Primary Purpose

Radiation Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 129-Xenon gas
MRI
Sponsored by
Bastiaan Driehuys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiation Injury focused on measuring Radiation induced lung injury, Xenon gas, hyperpolarized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients scheduled to undergo Radiation Therapy (RT)

Healthy volunteers

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.

Secondary Outcome Measures

Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)
"Gas exchange" is defined as the ratio of the signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the local 129Xe airspace signal. In other publications, the investigators have referred to this as "RBC (red blood cell) transfer". A "Gas Exchange Defect" is defined as any region of lung where the Gas Exchange signal is more than 2 standard deviations below the mean Gas Exchange signal of healthy volunteer subjects' lungs. "Gas Exchange Defect Percentage", or EDP, is defined as the volume of a subject's Gas Exchange Defects divided by the volume of the subject's lung, multiplied by 100%.
RBC (Red Blood Cell) to Barrier Ratio Following RT
"RBC:barrier ratio" is defined as the ratio of the whole lung signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the whole lung signal from 129Xe in the alveolar barrier tissue.
Change in High Barrier Uptake Percentage (HBUP) Following RT
"Barrier Uptake" is defined as the ratio of the regional signal from 129Xe dissolved in the interstitial space within the alveolar walls to the regional signal from 129Xe in the adjacent airspaces. "High Barrier Uptake" is defined as any region of lung where the Barrier Uptake signal is more than 2 standard deviations above the mean Barrier Uptake signal of healthy volunteer subjects' lungs. "High Barrier Uptake Percentage", or HBUP, is defined as the volume of a subject's lung exhibiting High Barrier Uptake divided by the total volume of the subject's lung, multiplied by 100%.

Full Information

First Posted
June 16, 2015
Last Updated
January 24, 2023
Sponsor
Bastiaan Driehuys
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02478255
Brief Title
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Official Title
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bastiaan Driehuys
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Injury
Keywords
Radiation induced lung injury, Xenon gas, hyperpolarized

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients scheduled to undergo Radiation Therapy (RT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 129-Xenon gas
Other Intervention Name(s)
Hyperpolarized 129Xe
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
Primary Outcome Measure Information:
Title
Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
Description
"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.
Time Frame
Baseline, following radiation treatment (up to 3 months)
Secondary Outcome Measure Information:
Title
Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)
Description
"Gas exchange" is defined as the ratio of the signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the local 129Xe airspace signal. In other publications, the investigators have referred to this as "RBC (red blood cell) transfer". A "Gas Exchange Defect" is defined as any region of lung where the Gas Exchange signal is more than 2 standard deviations below the mean Gas Exchange signal of healthy volunteer subjects' lungs. "Gas Exchange Defect Percentage", or EDP, is defined as the volume of a subject's Gas Exchange Defects divided by the volume of the subject's lung, multiplied by 100%.
Time Frame
Baseline, following RT (up to 3 months)
Title
RBC (Red Blood Cell) to Barrier Ratio Following RT
Description
"RBC:barrier ratio" is defined as the ratio of the whole lung signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the whole lung signal from 129Xe in the alveolar barrier tissue.
Time Frame
Baseline, following RT (up to 3 months)
Title
Change in High Barrier Uptake Percentage (HBUP) Following RT
Description
"Barrier Uptake" is defined as the ratio of the regional signal from 129Xe dissolved in the interstitial space within the alveolar walls to the regional signal from 129Xe in the adjacent airspaces. "High Barrier Uptake" is defined as any region of lung where the Barrier Uptake signal is more than 2 standard deviations above the mean Barrier Uptake signal of healthy volunteer subjects' lungs. "High Barrier Uptake Percentage", or HBUP, is defined as the volume of a subject's lung exhibiting High Barrier Uptake divided by the total volume of the subject's lung, multiplied by 100%.
Time Frame
Baseline, following RT (up to 3 months)
Other Pre-specified Outcome Measures:
Title
Change in Perfusion Defect Percentage (PDP) Following RT
Time Frame
Baseline, following RT (up to 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients: Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 Gy Willing and able to give informed consent and adhere to visit/protocol schedules Exclusion Criteria for Patients: Subject is less than 18 years old MRI is contraindicated based on responses to MRI Screening questionnaire Subject is pregnant or lactating Respiratory illness of a bacterial or viral etiology within 30 days of MRI Subject has any form of known cardiac arrhythmia Subject does not fit into 129Xe vest coil used for MRI Subject cannot hold his/her breath for 15 seconds Subject deemed unlikely to be able to comply with instructions during imaging 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Mammarappallil, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

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

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