Radiation InjuryPhase 2NCT02478255
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
A Phase 2 study testing Hyperpolarized 129-Xenon gas and MRI in people with Radiation Injury, run by Bastiaan Driehuys at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Injury
- What is being tested?
- Hyperpolarized 129-Xenon gas and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2016to 13 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27713
About this study
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.
- Conditions
- Radiation Injury
- Being tested
- Hyperpolarized 129-Xenon gas, MRI
- Keywords
- Radiation induced lung injury, Xenon gas, hyperpolarized
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129-Xenon gasDrug
Also called Hyperpolarized 129Xe
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.
MRIDevice
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled to undergo Radiation Therapy (RT) | Active comparator | 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. Receives: Drug: Hyperpolarized 129-Xenon gas; Device: MRI |
| Healthy volunteers | Active comparator | Not described Receives: Drug: Hyperpolarized 129-Xenon gas; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline, following radiation treatment (up to 3 months)
Secondary outcomes (3)
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%.
Measured: Baseline, following RT (up to 3 months)
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.
Measured: Baseline, following RT (up to 3 months)
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%.
Measured: Baseline, following RT (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start21 Mar 2016
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Joseph Mammarappallil, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478255
- Sponsor's protocol ID
- Pro00059856
- Other IDs
- 1R01HL105643-01
- Status last verified
- Jan 2023
- First submitted
- 16 Jun 2015
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
- ClinicalTrials.gov ID
- NCT02478255
- Acronym / sponsor ID
- Pro00059856
- Conditions
- Radiation Injury
- Keywords
- Radiation induced lung injury, Xenon gas, hyperpolarized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled to undergo Radiation Therapy (RT) | Active comparator | Drug: Hyperpolarized 129-Xenon gas, Device: MRIPatients 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. |
| Healthy volunteers | Active comparator | Drug: Hyperpolarized 129-Xenon gas, Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129-Xenon gasAlso: Hyperpolarized 129XeHyperpolarized 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. | Drug | Healthy volunteers, Patients scheduled to undergo Radiation Therapy (RT) |
| MRIConventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. | Device | Healthy volunteers, Patients scheduled to undergo Radiation Therapy (RT) |
Primary outcome
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%.
3 secondary outcomes
Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)
Time frame: Baseline, following RT (up to 3 months)
RBC (Red Blood Cell) to Barrier Ratio Following RT
Time frame: Baseline, following RT (up to 3 months)
Change in High Barrier Uptake Percentage (HBUP) Following RT
Time frame: Baseline, following RT (up to 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Mammarappallil, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized 129-Xenon gas and MRI in people with Radiation Injury, run by Bastiaan Driehuys at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP) (time frame: Baseline, following radiation treatment (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.