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Trial record 5 of 3674 for:    Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

129 Xenon MRI in Chronic Lung Disease

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ClinicalTrials.gov Identifier: NCT02723500
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

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) and ventilation defect volume obtained by analysis of hyperpolarized 129-Xe MRI.

Condition or disease Intervention/treatment Phase
Lung Disease Device: Hyperpolarized Xenon MRI Not Applicable

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 and/or diffusion weighted 129Xe MRI.

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) 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 the 129Xe chest coil 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease
Actual Study Start Date : August 2011
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
Drug Information available for: Xenon

Arm Intervention/treatment
MRI at baseline and over time
Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.
Device: Hyperpolarized Xenon MRI
Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.




Primary Outcome Measures :
  1. Ventilation Defect Percent (VDP) of the lung [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Apparent Diffusion Coefficients (ADC) of the lung [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723500


Contacts
Contact: Grace E Parraga, PhD 519-931-5265 gparraga@robarts.ca
Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 lreid@robarts.ca

Locations
Canada, Ontario
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5B7
Contact: Grace E Parraga, PhD    519-931-5265    gparraga@robarts.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario

Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT02723500     History of Changes
Other Study ID Numbers: ROB0031
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Dr. Grace Parraga, Western University, Canada:
Magnetic Resonance Imaging
Pulmonary Function

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs