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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT02748798
• Date of registration: 19/04/2016
• Prospective Registration: Yes
• Primary sponsor: Thunder Bay Regional Health Research Institute
• Public title: Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders
• Scientific title: Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders
• Date of first enrolment: November 10, 2020
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02748798
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

Canada

Contacts

• Name: Mitchell S Albert, PhD
• Affiliation: Thunder Bay Regional Health Research Institute

• Name: Mitchell S Albert, PhD

• Name: Mitchell S Albert, PhD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Lung Transplant

Mesothelioma

Chronic Obstructive Pulmonary Disease

Lung Infection

Pulmonary Embolism

Emphysema

Pulmonary Dysplasia

Pulmonary Hypertension

Asthma

Cold Virus

Lung Cancer

Lung Resection

Pulmonary Fibrosis

Interstitial Lung Disease

Obstructive Sleep Apnea

Seasonal Allergies

Bronchiectasis

Asbestosis

Intervention(s)

Device: 3He Human Lung Coil

Device: 129Xe Small and Large Human Lung Coil

Drug: HP 3He

Drug: PFP

Device: PFP and SF6 Human Lung Coil

Drug: SF6

Drug: HP 129Xe

Primary Outcome(s)

Signal to Noise Ratio [Time Frame: 2 years]

Secondary Outcome(s)

Correlation with PFTs [Time Frame: 2 years]

Secondary ID(s)

RP-312-07112014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lakehead University

St. Joseph's Care Group

Thunder Bay Regional Health Sciences Centre