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Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders

Primary Purpose

Lung Transplant, Lung Resection, Lung Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
HP 3He
HP 129Xe
PFP
SF6
129Xe Small and Large Human Lung Coil
3He Human Lung Coil
PFP and SF6 Human Lung Coil
Sponsored by
Thunder Bay Regional Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Transplant

Eligibility Criteria

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

Inclusion Criteria:

  • Is either:

    1. A healthy volunteer (i.e.: someone not diagnosed with a lung disorder written below; this may include smokers who have not been diagnosed with a lung disorder) or
    2. Has been diagnosed with one of the following respiratory disorders: lung transplants, lung resection, lung cancer, asthma, cystic fibrosis, chronic obstructive pulmonary disease, emphysema, mesothelioma, asbestosis, pulmonary embolism, interstitial lung disease, pulmonary fibrosis, bronchiectasis, seasonal allergies, pneumonia, cold virus, lung infection, pulmonary hypertension, pulmonary dysplasia, obstructive sleep apnea
  • Able to provide informed consent
  • Able to hold their breath for imaging:

    1. Healthy volunteers enrolled in this study must be able to hold their breath for 25 seconds
    2. Lung disorder participants must be able to hold their breath for 15 seconds

Exclusion Criteria:

  • Have contraindication to MR imaging (i.e. ferrous implants, cardiac pacemakers) - determined by MR screening prior to scans.
  • Have a history of claustrophobia.
  • Female exclusion only: are or may be pregnant.
  • Requires an oxygen mask and cannot use a nasal cannula.
  • Blood oxygen saturation is below 92% (measured at rest in a sitting position, and with an O2 nasal cannula if the participant normally uses one).
  • Has had an acute respiratory infection in the past 10 days.
  • Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor.
  • Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor.
  • Is currently an employee of the PI at the Thunder Bay Regional Research Institute (TBRRI) and/or Lakehead University.

Sites / Locations

  • Thunder Bay Regional RIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Participants

Lung Disorder Participants

Arm Description

Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.

Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.

Outcomes

Primary Outcome Measures

Signal to Noise Ratio
The primary objective of this study is to determine an optimized set of scan parameters that will produce clear, anatomically and clinically relevant images of the lungs for healthy participants and various types of lung disorder participants, and using one or more gas type (3He, 129Xe, PFP, SF6).

Secondary Outcome Measures

Correlation with PFTs
The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.

Full Information

First Posted
April 19, 2016
Last Updated
April 21, 2023
Sponsor
Thunder Bay Regional Health Research Institute
Collaborators
Thunder Bay Regional Health Sciences Centre, St. Joseph's Care Group, Lakehead University
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1. Study Identification

Unique Protocol Identification Number
NCT02748798
Brief Title
Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders
Official Title
Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thunder Bay Regional Health Research Institute
Collaborators
Thunder Bay Regional Health Sciences Centre, St. Joseph's Care Group, Lakehead University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research is to optimize the MRI system to obtain ideal lung images using Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned to the frequencies of these gases will be used. This study will take place at TBRHSC in the Cardiorespiratory Department and in the Research MRI facility.
Detailed Description
MR images of the lung obtained using HP 3He, HP 129Xe, and inert fluorinated gases essentially show the distribution of the inhaled gas inside the lungs. Measurements can be performed on these images to provide additional information that can be related to pulmonary function. Participation will involve at least two study visits. During the first visit, participants will provide written, informed consent, and undergo eligibility screening. Study drug administration, use of the investigational devices, and MR imaging for this study will be performed at the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre (TBRHSC). Pulmonary Function Tests (PFTs) will be performed at TBRHSC by a Registered Respiratory Therapist (RRT) and an MR Tech will be present for the duration of participant scans. Participants will be placed in the MRI with the appropriate chest coil wrapped around them like a vest. Several inhalation procedures will be carried out during scanning. Participants safety will be closely monitored throughout the entire study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant, Lung Resection, Lung Cancer, Asthma, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Emphysema, Mesothelioma, Asbestosis, Pulmonary Embolism, Interstitial Lung Disease, Pulmonary Fibrosis, Bronchiectasis, Seasonal Allergies, Cold Virus, Lung Infection, Pulmonary Hypertension, Pulmonary Dysplasia, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Participants
Arm Type
Experimental
Arm Description
Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.
Arm Title
Lung Disorder Participants
Arm Type
Experimental
Arm Description
Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.
Intervention Type
Drug
Intervention Name(s)
HP 3He
Other Intervention Name(s)
Hyperpolarized helium 3
Intervention Description
3He will be hyperpolarized using a custom-built polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of helium gas.
Intervention Type
Drug
Intervention Name(s)
HP 129Xe
Other Intervention Name(s)
Hyperpolarized xenon 129
Intervention Description
129Xe will be hyperpolarized using a Xemed polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of xenon gas.
Intervention Type
Drug
Intervention Name(s)
PFP
Other Intervention Name(s)
Perfluoropropane
Intervention Description
Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing.
Intervention Type
Drug
Intervention Name(s)
SF6
Other Intervention Name(s)
Sulfur hexafluoride
Intervention Description
Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing.
Intervention Type
Device
Intervention Name(s)
129Xe Small and Large Human Lung Coil
Intervention Description
The investigational 129Xe small and large quadrature lung coils are sensitive to 129Xe resonant frequencies and therefore will be paired with the investigational drug 129Xe. The size of the coil used will depend on the participants' body size.
Intervention Type
Device
Intervention Name(s)
3He Human Lung Coil
Intervention Description
The investigational 3He quadrature lung coil is sensitive to 3He resonant frequencies and therefore will be paired with the investigational drug 3He.
Intervention Type
Device
Intervention Name(s)
PFP and SF6 Human Lung Coil
Intervention Description
The investigational PFP and SF6 quadrature lung coil is sensitive to inert fluorinated gas resonant frequencies and therefore will be paired with both PFP and SF6.
Primary Outcome Measure Information:
Title
Signal to Noise Ratio
Description
The primary objective of this study is to determine an optimized set of scan parameters that will produce clear, anatomically and clinically relevant images of the lungs for healthy participants and various types of lung disorder participants, and using one or more gas type (3He, 129Xe, PFP, SF6).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlation with PFTs
Description
The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is either: A healthy volunteer (i.e.: someone not diagnosed with a lung disorder written below; this may include smokers who have not been diagnosed with a lung disorder) or Has been diagnosed with one of the following respiratory disorders: lung transplants, lung resection, lung cancer, asthma, cystic fibrosis, chronic obstructive pulmonary disease, emphysema, mesothelioma, asbestosis, pulmonary embolism, interstitial lung disease, pulmonary fibrosis, bronchiectasis, seasonal allergies, pneumonia, cold virus, lung infection, pulmonary hypertension, pulmonary dysplasia, obstructive sleep apnea Able to provide informed consent Able to hold their breath for imaging: Healthy volunteers enrolled in this study must be able to hold their breath for 25 seconds Lung disorder participants must be able to hold their breath for 15 seconds Exclusion Criteria: Have contraindication to MR imaging (i.e. ferrous implants, cardiac pacemakers) - determined by MR screening prior to scans. Have a history of claustrophobia. Female exclusion only: are or may be pregnant. Requires an oxygen mask and cannot use a nasal cannula. Blood oxygen saturation is below 92% (measured at rest in a sitting position, and with an O2 nasal cannula if the participant normally uses one). Has had an acute respiratory infection in the past 10 days. Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor. Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor. Is currently an employee of the PI at the Thunder Bay Regional Research Institute (TBRRI) and/or Lakehead University.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell S Albert, PhD
Phone
807-684-7270
Email
albertmi@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Yurii Shepelytskyi, MSc
Phone
807-684-6958
Email
yshepely@lakeheadu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Albert, PhD
Organizational Affiliation
Thunder Bay Regional Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional RI
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell S Albert, PhD
Phone
8076847270
Email
albertmi@tbh.net
First Name & Middle Initial & Last Name & Degree
Yurii Shepelytskyi, MSc
Phone
8076846958
Email
yshepely@lakeheadu.ca
First Name & Middle Initial & Last Name & Degree
Mitchell S Albert, PhD
First Name & Middle Initial & Last Name & Degree
Birubi Biman, MD
First Name & Middle Initial & Last Name & Degree
Karl Granberg, MD
First Name & Middle Initial & Last Name & Degree
Yurii Shepelytskyi, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25228404
Citation
Couch MJ, Blasiak B, Tomanek B, Ouriadov AV, Fox MS, Dowhos KM, Albert MS. Hyperpolarized and inert gas MRI: the future. Mol Imaging Biol. 2015 Apr;17(2):149-62. doi: 10.1007/s11307-014-0788-2.
Results Reference
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Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders

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