Clinical trial NCT02748798: Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders
Official title: Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
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
Lead sponsor: Thunder Bay Regional Health Research Institute
Sponsor class: OTHER
Collaborators: name: Thunder Bay Regional Health Sciences Centre
name: St. Joseph's Care Group
name: Lakehead University
First posted: 2016-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Signal to Noise Ratio
timeFrame: 2 years
Secondary outcomes:
measure: Correlation with PFTs
timeFrame: 2 years
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional RI
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Research Institute
name: Mitchell S Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.