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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-10-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02740868

Cystic Fibrosis Asthma

RECRUITING PHASE2

Functional Applications of Hyperpolarized 129Xe MRI

NCT01697332

Chronic Obstructive Pulmonary Disease

TERMINATED PHASE1/PHASE2

Functional MR Lung Imaging Using Hyperpolarised 129Xe

NCT02976935

COPD IPF

COMPLETED

Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

NCT04624490

Asthma COPD Interstitial Lung Disease +4 more

RECRUITING PHASE1

Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

NCT02279329

COPD Bronchiectasis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

HP 3He

Intervention Type DRUG

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.

HP 129Xe

Intervention Type DRUG

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.

PFP

Intervention Type DRUG

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

SF6

Intervention Type DRUG

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

129Xe Small and Large Human Lung Coil

Intervention Type DEVICE

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.

3He Human Lung Coil

Intervention Type DEVICE

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

PFP and SF6 Human Lung Coil

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

HP 3He

Intervention Type DRUG

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.

HP 129Xe

Intervention Type DRUG

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.

PFP

Intervention Type DRUG

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

SF6

Intervention Type DRUG

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

129Xe Small and Large Human Lung Coil

Intervention Type DEVICE

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.

3He Human Lung Coil

Intervention Type DEVICE

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

PFP and SF6 Human Lung Coil

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

PFP

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

Intervention Type DRUG

SF6

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

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hyperpolarized helium 3 Hyperpolarized xenon 129 Perfluoropropane Sulfur hexafluoride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes