Status:

RECRUITING

129 Xenon MRI in Chronic Lung Disease

Lead Sponsor:

Western University, Canada

Conditions:

Lung Disease

Eligibility:

All Genders

18-85 years

Phase:

NA

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...

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....

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.)

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT02723500

Start Date

August 1 2011

End Date

December 1 2025

Last Update

June 13 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, Canada, N6A 5B7

129 Xenon MRI in Chronic Lung Disease | DecenTrialz