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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748798
• Other study ID #: RP-312-07112014
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 10, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: April 2023
• Source: Thunder Bay Regional Health Research Institute
• Contact: Mitchell S Albert, PhD
• Phone: 807-684-7270
• Email: albertmi[@]tbh.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asbestosis
• Asthma
• Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Cold Virus
• Cystic Fibrosis
• Embolism
• Emphysema
• Fibrosis
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Lung Infection
• Lung Resection
• Lung Transplant
• Mesothelioma
• Obstructive Sleep Apnea
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Dysplasia
• Pulmonary Embolism
• Pulmonary Fibrosis
• Pulmonary Hypertension
• Seasonal Allergies
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Thunder Bay Regional RI	Thunder Bay	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Thunder Bay Regional Health Research Institute	Lakehead University, St. Joseph's Care Group, Thunder Bay Regional Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation with PFTs	The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.	2 years