Developing Optimal Parameters For Hyperpolarized Noble Gas And Inert Fluorinated Gas MRI Of Lung Disorders

Study Overview

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

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.

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.

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

RP-312-07112014

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-04-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-08
First Submitted that Met QC Criteria 2016-04-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-15
First Posted (ACTUAL) 2016-04-22	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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 con	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. 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. DRUG: PFP Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing. DRUG: SF6 Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing. 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 con	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. 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. DRUG: PFP Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing. DRUG: SF6 Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing. 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.

Participant Group/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 con

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.

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.

DRUG: PFP

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

DRUG: SF6

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

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

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.

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.

DRUG: PFP

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

DRUG: SF6

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

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	Measure Description	Time Frame
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).	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Correlation with PFTs	The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Is either:

Able to provide informed consent
Able to hold their breath for imaging:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Thunder Bay Regional Health Sciences Centre
St. Joseph's Care Group
Lakehead University

Investigators

PRINCIPAL_INVESTIGATOR: Mitchell S Albert, PhD, Thunder Bay Regional Health Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
Kooner HK, McIntosh MJ, Matheson AM, Venegas C, Radadia N, Ho T, Haider EA, Konyer NB, Santyr GE, Albert MS, Ouriadov A, Abdelrazek M, Kirby M, Dhaliwal I, Nicholson JM, Nair P, Svenningsen S, Parraga G. 129Xe MRI ventilation defects in ever-hospitalised and never-hospitalised people with post-acute COVID-19 syndrome. BMJ Open Respir Res. 2022 May;9(1):e001235. doi: 10.1136/bmjresp-2022-001235.
Matheson AM, McIntosh MJ, Kooner HK, Lee J, Desaigoudar V, Bier E, Driehuys B, Svenningsen S, Santyr GE, Kirby M, Albert MS, Shepelytskyi Y, Grynko V, Ouriadov A, Abdelrazek M, Dhaliwal I, Nicholson JM, Parraga G. Persistent 129Xe MRI Pulmonary and CT Vascular Abnormalities in Symptomatic Individuals with Post-acute COVID-19 Syndrome. Radiology. 2022 Nov;305(2):466-476. doi: 10.1148/radiol.220492. Epub 2022 Jun 28.

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