NCT02748798

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

Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Thunder Bay Regional Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-10-16
• Completion: 2021-10-16
• First posted: 2016-04-22
• Last updated: 2024-10-15

Locations

1 site across 1 country: Canada