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Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02740868
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Giles Santyr, The Hospital for Sick Children

Brief Summary:
Aim of this study is to evaluate image quality and reproducibility of Xenon-129 Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls using Xenon-129 MRI.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Asthma Drug: Xenon-129 Device: Magnetic Resonance Imaging Device: Lung Clearance Index Phase 2

Detailed Description:

Hyperpolarized noble gas magnetic resonance (MR) lung imaging is a relatively new imaging method that allows depiction of both lung function and morphology. Hyperpolarized gases are a new class of MR contrast agent which, when inhaled, provide high temporal and spatial resolution MR images of the lung airspaces. Since no ionizing radiation is involved, hyperpolarized gas MR imaging is ideal for the evaluation of lung diseases especially in children. With hyperpolarized gases, the nuclear spins of the gas atoms are brought into alignment outside of the MR scanner via a process called optical pumping; this yields high polarizations and permits visualization of the lung airspaces with MR imaging (despite the low physical density of the gas in the lung). Two non-radioactive (i.e. stable) isotopes of noble gases helium-3 and xenon-129 can be hyperpolarized. Until recently, higher polarizations could be achieved with helium-3 than with xenon-129, so in humans, helium-3 was more commonly used for hyperpolarized gas MR imaging of the lungs. Recently, the technology has been developed to provide large quantities of highly polarized xenon-129. Helium-3 gas is also extremely expensive and since there are limited reserves of the gas, difficult to procure for research. Unlike helium-3, since xenon-129 is naturally present in the atmosphere, it is less expensive and easier to procure for imaging.

Several applications of xenon-129 MR imaging are under development, including diffusion-weighted and relaxation-weighted imaging. These techniques take advantage of the fact that the rate of loss of xenon-129 polarization is significantly influenced by the local blood flow and concentration of molecular oxygen, as well as the restriction of xenon-129 diffusion by small airway space dimensions. These data can be used to create maps of the lung reflecting regional ventilation/perfusion and micro-airway sizes. Other data that can be obtained with xenon-129 MRI include the volumes of ventilated and unventilated lungs which can subsequently be analyzed to determine the homogeneity of gas distribution within the airspaces. These data can be used to study the structural and functional changes taking place in the lungs associated with pulmonary diseases like CF and asthma. It might provide a diagnostic tool that is able to detect pulmonary diseases more sensitively than the current gold standard measurements of spirometry and plethysmography, and thus prevent irreparable and irreversible damage to the lungs in the early stages of disease.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease
Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Active Comparator: Healthy
Healthy Participants ages 8 and older. Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Participants will undergo magnetic resonance imaging and lung clearance index.
Drug: Xenon-129
Xenon gas to be inhaled by research participants
Other Name: 129Xe

Device: Magnetic Resonance Imaging
Lung imaging will be performed for participants using MRI for all 3 arms
Other Name: MRI

Device: Lung Clearance Index
Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms
Other Name: LCI

Active Comparator: Cystic Fibrisos
Participants with cystic fibrosis ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Participants will undergo magnetic resonance imaging and lung clearance index.
Drug: Xenon-129
Xenon gas to be inhaled by research participants
Other Name: 129Xe

Device: Magnetic Resonance Imaging
Lung imaging will be performed for participants using MRI for all 3 arms
Other Name: MRI

Device: Lung Clearance Index
Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms
Other Name: LCI

Active Comparator: Asthma
Participants with asthma ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Participants will undergo magnetic resonance imaging and lung clearance index.
Drug: Xenon-129
Xenon gas to be inhaled by research participants
Other Name: 129Xe

Device: Magnetic Resonance Imaging
Lung imaging will be performed for participants using MRI for all 3 arms
Other Name: MRI

Device: Lung Clearance Index
Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms
Other Name: LCI




Primary Outcome Measures :
  1. Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement [ Time Frame: 1 year ]
    Ventilation defect percent (VDP) will measure the unventilated lung volume normalized to the total lung volume to give a ventilation defect percent (VDP) value. VDP will range from 0-100% with 0 being healthy.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants male and female aged 8 years old and older.
  2. Participants have no smoking history.
  3. For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
  4. Participants should have a FEV1%pred value greater than 40%.
  5. Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
  6. Participant must be able to perform a breath hold for 16s.
  7. Participant able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater).

Exclusion Criteria:

  1. Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material.
  2. Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
  3. Participant has had a cold or respiratory infection in the last four weeks.
  4. Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
  5. Participant is unable to perform spirometry or plethysmography maneuvers.
  6. Participant is pregnant or lactating.
  7. In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
  8. Participant has an MRI incompatible 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 prosthetic, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740868


Contacts
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Contact: Giles Santyr, PhD 416-813-7654 ext 301394 giles.santyr@sickkids.ca
Contact: Saidah Hack, BSc 4167281662 ext 307937 saidah.hack@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Principal Investigator: Giles Santyr, PhD FCCPM         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Giles Santyr, PhD The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giles Santyr, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02740868     History of Changes
Other Study ID Numbers: 1000048243
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Giles Santyr, The Hospital for Sick Children:
Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy

Additional relevant MeSH terms:
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Lung Diseases
Fibrosis
Cystic Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs