Radiation Induced Lung Injury (RILI)RILINCT03431129
Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation
An observational study of Radiation Induced Lung Injury (RILI), run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this work is to perform hyperpolarized (HP) 129Xe MRI in human subjects undergoing thoracic radiation therapy (RT), both before, during and following RT. HP 129Xe MR images will be analysed to provide maps of ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Induced Lung Injury (RILI)
- What is being tested?
- Hyperpolarized gas and proton lung MRI
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Participant will be recruited from Princess Margaret Hospital, Toronto, Ontario and Juravinski Cancer Centre, Hamilton, Ontario.
Inclusion Criteria:a) Patients 18 years of age or older; b) Diagnosis of locally advanced lung/esophageal/laryngeal or other type of cancer requiring radical intent RT to the thorax (with or without concurrent chemotherapy), consisting of 1.8 - 2 Gy daily fractions delivered over 5 - 6 weeks; c) Eastern Cooperative Oncology Group performance status 0 or 1; d) Preserved lung function as determined by a forced expiratory volume in 1 second (FEV1) > 70% to exclude patients with existing respiratory disorders (e.g. COPD, asthma etc.)
Exclusion Criteria:a) Planned anti-cancer surgery after radical RT; b) Chronic use of corticosteroids; c) Any previous RT to the thorax; d) History of ataxia telangiectasia or other known conditions that may increase radio-sensitivity; e) Planned for other anticancer therapy apart from RT or concurrent chemotherapy/RT f) Currently pregnant or lactating; g) Psychiatric or addictive disorders that would preclude obtaining informed consent or adherence to protocol; h) Inability to travel to obtain MRI scans; i) Any contraindications to MRI including but not limited to severe claustrophobia, implanted devices, aneurysm clips, neurostimulators (patients will be prescreened prior to registration).
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Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this work is to perform hyperpolarized (HP) 129Xe MRI in human subjects undergoing thoracic radiation therapy (RT), both before, during and following RT. HP 129Xe MR images will be analysed to provide maps of ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange. These results will be combined to yield a new measure of RILI, (i.e. dose volume histograms; DVHV/Q) and compared with conventional dose volume histograms (DVH), pulmonary function tests (PFTs), quality of life (QOL) questionnaire and CT measurements for assessment of RILI at each time point. The aim is to development a novel method for early and more sensitive method of detecting RILI before irreversible lung damage happens.
Read the detailed description
Briefly, at the beginning of an approximate three hour study visit, the qualified investigator (QI) / delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure. Following the explanation of the study, written informed consent will be collected. During the study visit, participants will undergo: 1) brief medical history and clinical examination, 2) full pulmonary function tests, 3) proton MRI, 4) HP 129Xe MRI. Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age, gender, height, weight, heart rate, respiratory rate, oral temperature and blood pressure. The QI/delegate, during a brief conversation with the participant, will collect relevant medical history from the participant to make sure the participant meets all the inclusion/exclusion criteria for the study. The QI will also make sure that the participant understands the study procedure and is willing to participate in the study. At each study visit at SickKids, the QI or delegate will also administer the QOL questionnaire to the participant. Based on the clinical examination results, medical history and the pulmonary function test results, the QI/delegate will determine if all the inclusion/exclusion criteria are met to proceed with the MRI part of the study visit.
- Conditions
- Radiation Induced Lung Injury (RILI)
- Being tested
- Hyperpolarized gas and proton lung MRI
- Keywords
- Xenon MRI, Lung, Radiation Induced Lung Injury,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized gas and proton lung MRIDiagnostic test
Lung MRI for participants undergoing radiation therapy (RT)
What is being measured
The primary outcome is the main question the study is designed to answer.
DVHV/Q
In-house software will be used to generate the ventilation, perfusion and gas exchange maps and calculate DVHV/Q
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Sep 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Insufficient recruitment and not enough funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Induced Lung Injury (RILI)Studies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giles Santyr, The Hospital for Sick Children
- Investigators
- Giles Santyr, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431129
- Sponsor's protocol ID
- 1000056200
- Acronym
- RILI
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2018
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared between the three participating sites in the study. A data transfer agreement has been implemented to enable this transfer smoothly.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation
- ClinicalTrials.gov ID
- NCT03431129
- Acronym / sponsor ID
- RILI / 1000056200
- Conditions
- Radiation Induced Lung Injury (RILI)
- Keywords
- Xenon MRI, Lung, Radiation Induced Lung Injury,
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment and not enough funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
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 work is to perform hyperpolarized (HP) 129Xe MRI in human subjects undergoing thoracic radiation therapy (RT), both before, during and following RT. HP 129Xe MR images will be analysed to provide maps of ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange. These results will be combined to yield a new measure of RILI, (i.e. dose volume histograms; DVHV/Q) and compared with conventional dose volume histograms (DVH), pulmonary function tests (PFTs), quality of life (QOL) questionnaire and CT measurements for assessment of RILI at each time point. The aim is to development a novel method for early and more sensitive method of detecting RILI before irreversible lung damage happens.
Detailed description
Briefly, at the beginning of an approximate three hour study visit, the qualified investigator (QI) / delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure. Following the explanation of the study, written informed consent will be collected. During the study visit, participants will undergo: 1) brief medical history and clinical examination, 2) full pulmonary function tests, 3) proton MRI, 4) HP 129Xe MRI. Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age, gender, height, weight, heart rate, respiratory rate, oral temperature and blood pressure. The QI/delegate, during a brief conversation with the participant, will collect relevant medical history from the participant to make sure the participant meets all the inclusion/exclusion criteria for the study. The QI will also make sure that the participant understands the study procedure and is willing to participate in the study. At each study visit at SickKids, the QI or delegate will also administer the QOL questionnaire to the participant. Based on the clinical examination results, medical history and the pulmonary function test results, the QI/delegate will determine if all the inclusion/exclusion criteria are met to proceed with the MRI part of the study visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant will be recruited from Princess Margaret Hospital, Toronto, Ontario and Juravinski Cancer Centre, Hamilton, Ontario.
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 gas and proton lung MRILung MRI for participants undergoing radiation therapy (RT) | Diagnostic test | – |
Primary outcome
DVHV/Q
Time frame: 2 years
In-house software will be used to generate the ventilation, perfusion and gas exchange maps and calculate DVHV/Q
Results and safety
The study was stopped early (reason given: Insufficient recruitment and not enough funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be shared between the three participating sites in the study. A data transfer agreement has been implemented to enable this transfer smoothly.
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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.
Giles Santyr, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Induced Lung Injury (RILI), run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 1 Aug 2025. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment and not enough funding). Results are not available in the source record.
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?
DVHV/Q (time frame: 2 years). 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 1 Aug 2025.