Clinical trial NCT02723500: 129 Xenon MRI in Chronic Lung Disease
Official title: A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Disease
Keywords: Magnetic Resonance Imaging
Pulmonary Function
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP) and pulmonary gas exchange measurements obtained by analysis of hyperpolarized 129-Xe MRI.

Detailed description: Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:

1. brief medical history and vital signs,
2. full pulmonary function tests,
3. proton MRI,
4. spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI,
5. Low-dose thoracic CT

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Multiple Breath Nitrogen Washout (MBNW) to measure Lung Clearance Index (LCI), and Forced Oscillation Technique (FOT) will be performed according to American Thoracic Society (ATS) guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, Minnesota USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, Massachusetts USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one of three 129-Xe chest coils fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation. Thoracic low dose CT will be performed with the same inhalation breath-hold volume and maneuver (nitrogen gas only) used for MRI to obtain participant-specific high resolution images of lung anatomy (tissue structure and airway morphology).

Eligibility criteria: Inclusion Criteria:

* Subjects male and female aged 18-85 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM)
* Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
* Subject must be able to perform a breathhold for 16s.
* Subject is judged to be in otherwise stable health on the basis of medical history
* Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume at one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
* FEV1 \>25% predicted
* Forced Vital Capacity (FVC)\> 25% predicted and \>0.5 liter

Exclusion Criteria:

* Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.
* Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine.
* Patient is unable to perform spirometry or plethysmography maneuvers
* Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
* Patient is pregnant or lactating
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
* Subject has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)

Primary outcomes:
measure: Ventilation Defect Percent (VDP) of the lung
timeFrame: 5 years
Secondary outcomes:
measure: Apparent Diffusion Coefficients (ADC) of the lung
timeFrame: 5 years
measure: Dissolved phase spectroscopy measurements
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Robarts Research Institute, The University of Western Ontario
name: Grace E Parraga, PhD
role: PRINCIPAL_INVESTIGATOR
References: