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

T

Thunder Bay Regional Health Research Institute

Status and phase

Enrolling
Early Phase 1

Conditions

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

Treatments

Drug: HP 3He
Drug: PFP
Device: 3He Human Lung Coil
Drug: SF6
Device: PFP and SF6 Human Lung Coil
Device: 129Xe Small and Large Human Lung Coil
Drug: HP 129Xe

Study type

Interventional

Funder types

Other

Identifiers

NCT02748798
RP-312-07112014

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Healthy Participants
Experimental group
Description:
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.
Treatment:
Drug: HP 129Xe
Device: 129Xe Small and Large Human Lung Coil
Device: PFP and SF6 Human Lung Coil
Drug: SF6
Device: 3He Human Lung Coil
Drug: PFP
Drug: HP 3He
Lung Disorder Participants
Experimental group
Description:
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.
Treatment:
Drug: HP 129Xe
Device: 129Xe Small and Large Human Lung Coil
Device: PFP and SF6 Human Lung Coil
Drug: SF6
Device: 3He Human Lung Coil
Drug: PFP
Drug: HP 3He

Trial contacts and locations

1

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Central trial contact

Yurii Shepelytskyi, MSc; Mitchell S Albert, PhD

Data sourced from clinicaltrials.gov

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