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Completed

NCT Number: NCT02478255

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

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.

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Key information

Conditions

Radiation Injury Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.

Treatment and study plan

Hyperpolarized 129-Xenon gas

Drug

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 names: Hyperpolarized 129Xe

MRI

Device

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

Primary outcomes

  1. Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)

    Time frame: Baseline, following radiation treatment (up to 3 months)

    "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 outcomes

  1. Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)

    Time frame: Baseline, following RT (up to 3 months)

    "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%.

  2. RBC (Red Blood Cell) to Barrier Ratio Following RT

    Time frame: Baseline, following RT (up to 3 months)

    "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.

  3. Change in High Barrier Uptake Percentage (HBUP) Following RT

    Time frame: Baseline, following RT (up to 3 months)

    "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%.

Other outcomes

  1. Change in Perfusion Defect Percentage (PDP) Following RT

    Time frame: Baseline, following RT (up to 3 months)

Sponsors and collaborators

Lead sponsor

Bastiaan Driehuys

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2015
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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