129 Xenon MRI in Chronic Lung Disease

NCT02723500 | Recruiting

• 1 other identifier: ROB0031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Magnetic Resonance Imaging; Pulmonary Function

Outcome Measures

Primary Outcomes (1)

• Ventilation Defect Percent (VDP) of the lung

  VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.

  5 years

Secondary Outcomes (2)

• Apparent Diffusion Coefficients (ADC) of the lung

  5 years

• Dissolved phase spectroscopy measurements

  5 years

Study Arms (1)

MRI at baseline and over time

OTHER

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

Device: Hyperpolarized Xenon MRI

Interventions

Hyperpolarized Xenon MRI DEVICE

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.

MRI at baseline and over time

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

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

London, Ontario, N6A 5B7, Canada

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@robarts.ca

Angela P Wilson, RRT

CONTACT

519-931-5777; awilson@robarts.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: March 30, 2016
• Study Start: August 1, 2011
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CA (1)