Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748798
Recruitment Status : Not yet recruiting
First Posted : April 22, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
Thunder Bay Regional Health Sciences Centre
St. Joseph's Care Group
Lakehead University
Information provided by (Responsible Party):
Thunder Bay Regional Research Institute

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.

Condition or disease Intervention/treatment Phase
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 Drug: HP 3He Drug: HP 129Xe Drug: PFP Drug: SF6 Device: 129Xe Small and Large Human Lung Coil Device: 3He Human Lung Coil Device: PFP and SF6 Human Lung Coil Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Healthy Participants
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.
Drug: HP 3He
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.
Other Name: Hyperpolarized helium 3

Drug: HP 129Xe
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.
Other Name: Hyperpolarized xenon 129

Drug: PFP
Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing.
Other Name: Perfluoropropane

Drug: SF6
Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing.
Other Name: Sulfur hexafluoride

Device: 129Xe Small and Large Human Lung Coil
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.

Device: 3He Human Lung Coil
The investigational 3He quadrature lung coil is sensitive to 3He resonant frequencies and therefore will be paired with the investigational drug 3He.

Device: PFP and SF6 Human Lung Coil
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.

Experimental: Lung Disorder Participants
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.
Drug: HP 3He
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.
Other Name: Hyperpolarized helium 3

Drug: HP 129Xe
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.
Other Name: Hyperpolarized xenon 129

Drug: PFP
Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing.
Other Name: Perfluoropropane

Drug: SF6
Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing.
Other Name: Sulfur hexafluoride

Device: 129Xe Small and Large Human Lung Coil
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.

Device: 3He Human Lung Coil
The investigational 3He quadrature lung coil is sensitive to 3He resonant frequencies and therefore will be paired with the investigational drug 3He.

Device: PFP and SF6 Human Lung Coil
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 Measures :
  1. Signal to Noise Ratio [ Time Frame: 2 years ]
    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 :
  1. Correlation with PFTs [ Time Frame: 2 years ]
    The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02748798


Contacts
Layout table for location contacts
Contact: Mitchell S Albert, PhD 807-684-7270 albertmi@tbh.net
Contact: Yurii Shepelytskyi, MSc 807-684-6958 yshepely@lakeheadu.ca

Locations
Layout table for location information
Canada, Ontario
Thunder Bay Regional RI Not yet recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Mitchell S Albert, PhD    8076847270    albertmi@tbh.net   
Contact: Yurii Shepelytskyi, PhD Candidate    8076846958    yshepely@lakeheadu.ca   
Principal Investigator: Mitchell S Albert, PhD         
Sub-Investigator: Birubi Biman, MD         
Sub-Investigator: Karl Granberg, MD         
Sub-Investigator: Yurii Shepelytskyi, PhD         
Sponsors and Collaborators
Thunder Bay Regional Research Institute
Thunder Bay Regional Health Sciences Centre
St. Joseph's Care Group
Lakehead University
Investigators
Layout table for investigator information
Principal Investigator: Mitchell S Albert, PhD Thunder Bay Regional Research Institute

Publications:
Layout table for additonal information
Responsible Party: Thunder Bay Regional Research Institute
ClinicalTrials.gov Identifier: NCT02748798     History of Changes
Other Study ID Numbers: RP-312-07112014
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mesothelioma
Cystic Fibrosis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Hypertension, Pulmonary
Pulmonary Fibrosis
Pulmonary Embolism
Bronchiectasis
Lung Diseases, Interstitial
Asbestosis
Embolism
Fibrosis
Emphysema
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Respiratory Tract Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases