129 Xenon MRI in Chronic Lung Disease

Launched by WESTERN UNIVERSITY, CANADA · Mar 23, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of MRI called hyperpolarized Xenon 129 (129-Xe MRI) to help understand lung diseases better. Researchers want to find new ways to measure how well air moves in and out of the lungs and how effectively the lungs exchange gases. The study is open to adults aged 18 to 85 who have been diagnosed with various lung conditions, such as asthma, COPD, or pulmonary fibrosis, and who are generally healthy enough to participate.

If you or a family member qualify, you can expect to undergo both the 129-Xe MRI and standard lung function tests. Participants need to be able to hold their breath for about 16 seconds and complete simple lung tests. It's important to note that some individuals may not be eligible if they have certain health issues, like severe claustrophobia or incompatible medical devices. This study aims to improve the tools doctors use to assess lung health, which could lead to better care for people with chronic lung diseases.

Gender

ALL

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.)