Recruiting

Xenon MRI

Sponsor:

Western University, Canada

Code:

NCT02723500

Conditions

Lung Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Xenon MRI

Study Details

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.

Conditions

Lung Disease

Study ID

NCT02723500

Start date

Aug, 2011

Status verified date

Jun, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: MRI at baseline and over time

Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

Interventions

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 measure

  • Ventilation Defect Percent (VDP) of the lung [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

Angela P Wilson, RRT

519-931-5777awilson@robarts.ca

Locations

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

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

More Information

Sponsor

Western University, Canada

Last update posted

Jun 13, 2024

Last verified

Jun, 2024

Keywords

  • Magnetic Resonance Imaging
  • Pulmonary Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-06-13.