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

Primary Purpose

Cystic Fibrosis, Asthma

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Xenon-129
Magnetic Resonance Imaging
Lung Clearance Index
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

    -

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Healthy

Cystic Fibrisos

Asthma

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement
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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2015
Last Updated
October 24, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02740868
Brief Title
Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease
Official Title
Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Asthma
Keywords
Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cystic Fibrisos
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Asthma
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xenon-129
Other Intervention Name(s)
129Xe
Intervention Description
Xenon gas to be inhaled by research participants
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Lung imaging will be performed for participants using MRI for all 3 arms
Intervention Type
Device
Intervention Name(s)
Lung Clearance Index
Other Intervention Name(s)
LCI
Intervention Description
Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms
Primary Outcome Measure Information:
Title
Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants male and female aged 8 years old and older. Participants have no smoking history. 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. Participants should have a FEV1%pred value greater than 40%. Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent. Participant must be able to perform a breath hold for 16s. 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: 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. Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension. Participant has had a cold or respiratory infection in the last four weeks. Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%. Participant is unable to perform spirometry or plethysmography maneuvers. Participant is pregnant or lactating. 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. 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). -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giles Santyr, PhD
Phone
416-813-7654
Ext
301394
Email
giles.santyr@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Braganza, BSc
Phone
4167281662
Ext
307937
Email
sharon.braganza@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giles Santyr, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giles Santyr, PhD FCCPM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33303537
Citation
Munidasa S, Couch MJ, Rayment JH, Voskrebenzev A, Seethamraju R, Vogel-Claussen J, Ratjen F, Santyr G. Free-breathing MRI for monitoring ventilation changes following antibiotic treatment of pulmonary exacerbations in paediatric cystic fibrosis. Eur Respir J. 2021 Apr 15;57(4):2003104. doi: 10.1183/13993003.03104-2020. Print 2021 Apr. No abstract available.
Results Reference
derived
PubMed Identifier
28245140
Citation
Kanhere N, Couch MJ, Kowalik K, Zanette B, Rayment JH, Manson D, Subbarao P, Ratjen F, Santyr G. Correlation of Lung Clearance Index with Hyperpolarized 129Xe Magnetic Resonance Imaging in Pediatric Subjects with Cystic Fibrosis. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1073-1075. doi: 10.1164/rccm.201611-2228LE. No abstract available.
Results Reference
derived

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

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