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

NCT02748798 | Terminated Early Phase 1

• 1 other identifier: RP-312-07112014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation with PFTs

  2 years

Study Arms (2)

Healthy Participants

EXPERIMENTAL

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.

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

Lung Disorder Participants

EXPERIMENTAL

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.

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

Interventions

HP 3He 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.

Also known as: Hyperpolarized helium 3

Healthy Participants; Lung Disorder Participants

HP 129Xe 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.

Also known as: Hyperpolarized xenon 129

Healthy Participants; Lung Disorder Participants

PFP DRUG

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

Also known as: Perfluoropropane

Healthy Participants; Lung Disorder Participants

SF6 DRUG

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

Also known as: Sulfur hexafluoride

Healthy Participants; Lung Disorder Participants

129Xe Small and Large Human Lung Coil 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.

Healthy Participants; Lung Disorder Participants

3He Human Lung Coil DEVICE

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

Healthy Participants; Lung Disorder Participants

PFP and SF6 Human Lung Coil 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.

Healthy Participants; Lung Disorder Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is either:
• 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
• 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:
• Healthy volunteers enrolled in this study must be able to hold their breath for 25 seconds
• Lung disorder participants must be able to hold their breath for 15 seconds

You may not qualify if:

• Have contraindication to MR imaging (i.e. ferrous implants, cardiac pacemakers) - determined by MR screening prior to scans.
• Have a history of claustrophobia.
• 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.

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead
• Thunder Bay Regional Health Sciences Centre: collaborator
• St. Joseph's Care Group: collaborator
• Lakehead University: collaborator

Study Sites (1)

Thunder Bay Regional RI

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Publications (3)

• 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.

  PMID: 25228404 BACKGROUND

• 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.

  PMID: 35584850 RESULT

• 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.

  PMID: 35762891 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Asthma; Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive; Emphysema; Mesothelioma; Asbestosis; Pulmonary Embolism; Lung Diseases, Interstitial; Pulmonary Fibrosis; Bronchiectasis; Rhinitis, Allergic, Seasonal; Hypertension, Pulmonary; Sleep Apnea, Obstructive

Interventions

perflutren; Sulfur Hexafluoride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pneumoconiosis; Lung Injury; Occupational Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases; Hypertension; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Study Officials

• Mitchell S Albert, PhD

  Thunder Bay Regional Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 22, 2016
• Study Start: November 10, 2020
• Primary Completion: October 16, 2021
• Study Completion: October 16, 2021
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CA (1)