Bronchiolitis ObliteransBOS-MRINCT04029636
Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC
An observational study of Bronchiolitis Obliterans, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The development of bronchiolitis obliterans syndrome (BOS) and other late onset non-infectious pulmonary complications (LONIPCs) following hematopoietic stem cell transplantation (HSCT) is associated with a significantly worse prognosis, high disease burden, and excessive health resource utilization. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- Inhaled Hyperpolarized Xenon-129
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2019to Nov 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. For participants who have known LONIPC at enrollment (cross-sectional group) 2. For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD
Who may be able to join
- For participants who have known LONIPC at enrollment (cross-sectional group):
- Patient is 18 - 70 years old
- Patient has received an allogenic HSCT
- Diagnosed LONIPC
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Patient is 18 - 70 years old
Show all 10Show fewer
- Patient has received an allogenic HSCT in the last 24 months
- Patient has a new diagnosis of cGVHD within the last 6 months by criteria of:
- Moderate- or severe- cGVHD as per NIH consensus criteria, determined by a treating hematologist or
- cGVHD requiring immunosuppression with prednisone at a dose of > 0.5mg/kg/day, or alternate steroid-sparing agent
Who cannot join
- For participants who have known LONIPC at enrollment (cross-sectional group):
- Age less than 18 years or greater than 70 years of age
- Current smoker (quit in the last 3 months)
- Smoking history greater than 20 pack years
- Presence of contraindications to pulmonary function testing including myocardial infarction within the last one month, hemoptysis, active communicable disease (e.g. TB), inability to follow commands, thoracic/abdominal/eye surgery within the last 3 months, pneumothorax, uncontrolled hypertension (SBP > 180, DBP > 110) or pulmonary embolism, other contraindication as determined by technical staff.
- Pregnancy prior to or during study
Show all 19Show fewer
- In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio-prosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Age less than 18 years or greater than 70 years of age
- Known history of late onset non-infectious pulmonary complication (LONIPC) related to HSCT
- Current smoker (quit in the last 3 months)
- Smoking history greater than 20 pack years
- Presence of contraindications to pulmonary function testing including myocardial infarction within the last one month, hemoptysis, active communicable disease (e.g. TB), inability to follow commands, thoracic/abdominal/eye surgery within the last 3 months, pneumothorax, uncontrolled hypertension (SBP > 180, DBP > 110) or pulmonary embolism, other contraindication as determined by technical staff.
- Pregnancy prior to or during study
- In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio-prosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3
Jane Turner, MD, 905-906-2629, jane.turner@medportal.ca
About this study
Official title: Hyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell Transplantation
The development of bronchiolitis obliterans syndrome (BOS) and other late onset non-infectious pulmonary complications (LONIPCs) following hematopoietic stem cell transplantation (HSCT) is associated with a significantly worse prognosis, high disease burden, and excessive health resource utilization. In this proposal, the investigators plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs.
Read the detailed description
There is mounting evidence suggesting that current practice is failing to provide early detection of LONIPCs, before critical loss of lung function occurs. Furthermore, autopsy series in HSCT patients have revealed a wide spectrum of pulmonary pathology in different compartments of the lung (airway, parenchyma, interstitium) within the same individual. These findings imply that LONIPCs and the extent of their pulmonary involvement are under-recognized, which adversely impacts the clinical trajectory and outcomes of HSCT patients. These findings also suggest that the underlying pathophysiology is multi-faceted and diffuse, highlighting a need for a multi-modal approach to early detection, and better characterization of the spectrum of pulmonary involvement. In this study, we plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs. We propose an observational study using hyperpolarized magnetic resonance imaging (MRI) to capture the anatomical and functional spectrum of LONIPCs post-HSCT. Hyperpolarized magnetic resonance imaging (MRI) is a novel and noninvasive functional imaging method, with the capacity to evaluate pulmonary structure and function. Inhaled hyperpolarized gas (129Xenon) maps focal areas of ventilation defects, a functional consequence of small airway obstruction, which often goes undetected on PFT in early disease states. It can provide additional information on alveolar structure and gas diffusion, lending insight into pathology in other compartments. Oscillometry technique (FOT) is a non-invasive technique using wave frequency to map out large and small airways, commonly used in pediatric pulmonology. We propose to examine the 2 novel modalities in HSCT patients with and without LONIPC/BOS. We hypothesize that the use of functional-structural imaging and FOT will provide better characterization and the extent of LONIPCs in early diseases states post-HSCT. These findings will provide invaluable insight into the pathophysiology of LONIPCs, providing a platform for future research into the early diagnosis and treatment of these high-burden diseases.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- Inhaled Hyperpolarized Xenon-129
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Hyperpolarized Xenon-129Other
How hyperpolarized 129Xe MRI measurements of lung structure and function change over time in a population at high risk for LONIPC related to their transplant
| Study group | Role | What they receive |
|---|---|---|
| Established LONIPC | The first cohort will comprise of patients with established LONIPCs and the investigative procedures in this study will provide data on the scope of abnormalities and pathology across the spectrum of these conditions. Receives: Other: Inhaled Hyperpolarized Xenon-129 | |
| Trajectory of LONIPC | The second, prospectively followed, cohort will provide data on the sequence and temporal development of these abnormalities, and therefore provide information on the trajectory of LONIPCs Receives: Other: Inhaled Hyperpolarized Xenon-129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change detected in Ventilation Defect Percent (VDP) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
129Xe Ventilation Defect Percent (VDP): For analysis of 129Xe static ventilation MR images we will employ the same approach as described by Kirby and colleagues to quantify the VDP to assess ventilation. VDP is expressed as a percentage.
Measured: MRIs will be performed every three months for one year.
The change detected in Apparent Diffusion Coefficients (ADC) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
129Xe Apparent Diffusion Coefficients (ADC): For analysis of 129Xe diffusion-weighted MR images we will employ the same approach as described by Kirby and colleagues to quantify the ADC and generate ADC maps to assess airspace size. ADC is expressed in mm^2/s.
Measured: MRIs will be performed every three months for one year.
The change detected in Signal-to-noice Ration (SNR) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
129Xe Signal-to-noise Ratio (SNR): The signal-to-noise ratio will be calculated as the mean signal intensity in a region of interest within the lung divided by the standard deviation in a region of interest outside of the lung.
Measured: MRIs will be performed every three months for one year.
The change detected in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), total lung capacity (TLC), and residual volume (RV) in cross-sectional and prospectively followed cohorts.
FVC, FEV1, TLC, and RV will be documented in litres (L) through pulmonary function testing.
Measured: Pulmonary Function Tests (PFTs) will be performed as clinically indicated, which in this study population will be every three months for two years.
The change detected in FEV1/FVC ratio and RV/TLC ratio in cross-sectional and prospectively followed cohorts.
FEV1/FVC ratio and RV/TLC ratio will be documented; these are ratios therefore and therefore do not have units.
Measured: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
The change detected in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin in cross-sectional and prospectively followed cohorts.
Diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin will be recorded in L/min/mmHg.
Measured: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
The change detected in DLCO divided by alveolar volume (VA) [DLCO/VA, or transfer coefficient of the lung for carbon monoxide, KCO] in cross-sectional and prospectively followed cohorts.
DLCO divided by alveolar volume (DLCO/VA, or transfer coefficient of the lung for carbon monoxide [KCO]) will be recorded in mL/min/mmHg/L
Measured: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
The change detected in forced oscillometry technique (FOT) in cross-sectional and prospectively followed cohorts.
Results recorded in hertz (Hz)
Measured: Oscillometry will be recorded every three months for one year.
Secondary outcomes (3)
Change in airway resistance and reactance over time quantified by FOT
Measured in ohms (Ω)
Measured: Oscillometry will be recorded every three months for one year.
Development of Bronchiolitis Obliterans Syndrome (BOS)
The development of BOS will be defined using the National Institutes of Health (NIH) diagnostic criteria, and documented for all study participants (yes/no).
Measured: Development of BOS will be documented over the study's duration (2 years).
Development of clinical outcomes of death, hospitalization for respiratory cause, or respiratory failure.
The development of the above clinical outcomes will be documented for all study participants (yes/no).
Measured: Outcomes will be documented over the study's duration (2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis ObliteransStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Turner, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029636
- Sponsor's protocol ID
- 5996
- Acronym
- BOS-MRI
- Status last verified
- Jul 2019
- First submitted
- 7 Jun 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chien JW, Duncan S, Williams KM, Pavletic SZ. Bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation-an increasingly recognized manifestation of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2010 Jan;16(1 Suppl):S106-14. doi: 10.1016/j.bbmt.2009.11.002. Epub 2009 Nov 5.
PubMed 19896545Walkup LL, Myers K, El-Bietar J, Nelson A, Willmering MM, Grimley M, Davies SM, Towe C, Woods JC. Xenon-129 MRI detects ventilation deficits in paediatric stem cell transplant patients unable to perform spirometry. Eur Respir J. 2019 May 2;53(5):1801779. doi: 10.1183/13993003.01779-2018. Print 2019 May.
PubMed 30846475Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
PubMed 22104288Kirby M, Svenningsen S, Kanhere N, Owrangi A, Wheatley A, Coxson HO, Santyr GE, Paterson NA, McCormack DG, Parraga G. Pulmonary ventilation visualized using hyperpolarized helium-3 and xenon-129 magnetic resonance imaging: differences in COPD and relationship to emphysema. J Appl Physiol (1985). 2013 Mar 15;114(6):707-15. doi: 10.1152/japplphysiol.01206.2012. Epub 2012 Dec 13.
PubMed 23239874
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04029636
- Acronym / sponsor ID
- BOS-MRI / 5996
- Conditions
- Bronchiolitis Obliterans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 23 Jul 2019 (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 development of bronchiolitis obliterans syndrome (BOS) and other late onset non-infectious pulmonary complications (LONIPCs) following hematopoietic stem cell transplantation (HSCT) is associated with a significantly worse prognosis, high disease burden, and excessive health resource utilization. In this proposal, the investigators plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs.
Detailed description
There is mounting evidence suggesting that current practice is failing to provide early detection of LONIPCs, before critical loss of lung function occurs. Furthermore, autopsy series in HSCT patients have revealed a wide spectrum of pulmonary pathology in different compartments of the lung (airway, parenchyma, interstitium) within the same individual. These findings imply that LONIPCs and the extent of their pulmonary involvement are under-recognized, which adversely impacts the clinical trajectory and outcomes of HSCT patients. These findings also suggest that the underlying pathophysiology is multi-faceted and diffuse, highlighting a need for a multi-modal approach to early detection, and better characterization of the spectrum of pulmonary involvement. In this study, we plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs. We propose an observational study using hyperpolarized magnetic resonance imaging (MRI) to capture the anatomical and functional spectrum of LONIPCs post-HSCT. Hyperpolarized magnetic resonance imaging (MRI) is a novel and noninvasive functional imaging method, with the capacity to evaluate pulmonary structure and function. Inhaled hyperpolarized gas (129Xenon) maps focal areas of ventilation defects, a functional consequence of small airway obstruction, which often goes undetected on PFT in early disease states. It can provide additional information on alveolar structure and gas diffusion, lending insight into pathology in other compartments. Oscillometry technique (FOT) is a non-invasive technique using wave frequency to map out large and small airways, commonly used in pediatric pulmonology. We propose to examine the 2 novel modalities in HSCT patients with and without LONIPC/BOS. We hypothesize that the use of functional-structural imaging and FOT will provide better characterization and the extent of LONIPCs in early diseases states post-HSCT. These findings will provide invaluable insight into the pathophysiology of LONIPCs, providing a platform for future research into the early diagnosis and treatment of these high-burden diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Established LONIPC | – | Other: Inhaled Hyperpolarized Xenon-129The first cohort will comprise of patients with established LONIPCs and the investigative procedures in this study will provide data on the scope of abnormalities and pathology across the spectrum of these conditions. |
| Trajectory of LONIPC | – | Other: Inhaled Hyperpolarized Xenon-129The second, prospectively followed, cohort will provide data on the sequence and temporal development of these abnormalities, and therefore provide information on the trajectory of LONIPCs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. For participants who have known LONIPC at enrollment (cross-sectional group) 2. For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD
Key inclusion criteria (10 listed)
- For participants who have known LONIPC at enrollment (cross-sectional group):
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Patient is 18 - 70 years old
- Patient has received an allogenic HSCT in the last 24 months
- Patient has a new diagnosis of cGVHD within the last 6 months by criteria of:
Key exclusion criteria (19 listed)
- For participants who have known LONIPC at enrollment (cross-sectional group):
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Age less than 18 years or greater than 70 years of age
- Known history of late onset non-infectious pulmonary complication (LONIPC) related to HSCT
- Current smoker (quit in the last 3 months)
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 |
|---|---|---|
| Inhaled Hyperpolarized Xenon-129How hyperpolarized 129Xe MRI measurements of lung structure and function change over time in a population at high risk for LONIPC related to their transplant | Other | Established LONIPC, Trajectory of LONIPC |
Primary outcome
The change detected in Ventilation Defect Percent (VDP) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
Time frame: MRIs will be performed every three months for one year.
129Xe Ventilation Defect Percent (VDP): For analysis of 129Xe static ventilation MR images we will employ the same approach as described by Kirby and colleagues to quantify the VDP to assess ventilation. VDP is expressed as a percentage.
The change detected in Apparent Diffusion Coefficients (ADC) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
Time frame: MRIs will be performed every three months for one year.
129Xe Apparent Diffusion Coefficients (ADC): For analysis of 129Xe diffusion-weighted MR images we will employ the same approach as described by Kirby and colleagues to quantify the ADC and generate ADC maps to assess airspace size. ADC is expressed in mm^2/s.
The change detected in Signal-to-noice Ration (SNR) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts.
Time frame: MRIs will be performed every three months for one year.
129Xe Signal-to-noise Ratio (SNR): The signal-to-noise ratio will be calculated as the mean signal intensity in a region of interest within the lung divided by the standard deviation in a region of interest outside of the lung.
The change detected in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), total lung capacity (TLC), and residual volume (RV) in cross-sectional and prospectively followed cohorts.
Time frame: Pulmonary Function Tests (PFTs) will be performed as clinically indicated, which in this study population will be every three months for two years.
FVC, FEV1, TLC, and RV will be documented in litres (L) through pulmonary function testing.
The change detected in FEV1/FVC ratio and RV/TLC ratio in cross-sectional and prospectively followed cohorts.
Time frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
FEV1/FVC ratio and RV/TLC ratio will be documented; these are ratios therefore and therefore do not have units.
The change detected in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin in cross-sectional and prospectively followed cohorts.
Time frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
Diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin will be recorded in L/min/mmHg.
The change detected in DLCO divided by alveolar volume (VA) [DLCO/VA, or transfer coefficient of the lung for carbon monoxide, KCO] in cross-sectional and prospectively followed cohorts.
Time frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.
DLCO divided by alveolar volume (DLCO/VA, or transfer coefficient of the lung for carbon monoxide [KCO]) will be recorded in mL/min/mmHg/L
The change detected in forced oscillometry technique (FOT) in cross-sectional and prospectively followed cohorts.
Time frame: Oscillometry will be recorded every three months for one year.
Results recorded in hertz (Hz)
3 secondary outcomes
Change in airway resistance and reactance over time quantified by FOT
Time frame: Oscillometry will be recorded every three months for one year.
Development of Bronchiolitis Obliterans Syndrome (BOS)
Time frame: Development of BOS will be documented over the study's duration (2 years).
Development of clinical outcomes of death, hospitalization for respiratory cause, or respiratory failure.
Time frame: Outcomes will be documented over the study's duration (2 years).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 19896545Chien JW, Duncan S, Williams KM, Pavletic SZ. Bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation-an increasingly recognized manifestation of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2010 Jan;16(1 Suppl):S106-14. doi: 10.1016/j.bbmt.2009.11.002. Epub 2009 Nov 5.
- Background: PubMed 30846475Walkup LL, Myers K, El-Bietar J, Nelson A, Willmering MM, Grimley M, Davies SM, Towe C, Woods JC. Xenon-129 MRI detects ventilation deficits in paediatric stem cell transplant patients unable to perform spirometry. Eur Respir J. 2019 May 2;53(5):1801779. doi: 10.1183/13993003.01779-2018. Print 2019 May.
- Background: PubMed 22104288Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
- Background: PubMed 23239874Kirby M, Svenningsen S, Kanhere N, Owrangi A, Wheatley A, Coxson HO, Santyr GE, Paterson NA, McCormack DG, Parraga G. Pulmonary ventilation visualized using hyperpolarized helium-3 and xenon-129 magnetic resonance imaging: differences in COPD and relationship to emphysema. J Appl Physiol (1985). 2013 Mar 15;114(6):707-15. doi: 10.1152/japplphysiol.01206.2012. Epub 2012 Dec 13.
- Individual participant dataSharing planned: No
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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.
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 Bronchiolitis Obliterans, run by Hamilton Health Sciences Corporation 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?
The sponsor lists 10 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 23 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Turner, MD (905-906-2629, jane.turner@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change detected in Ventilation Defect Percent (VDP) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts. (time frame: MRIs will be performed every three months for one year.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029636, which also lists 4 linked publications.
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 23 Jul 2019.