A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease

Launched by WESTERN UNIVERSITY, CANADA · Mar 29, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at how a special type of MRI, using hyperpolarized helium, can help doctors understand lung diseases better. The study aims to gather information about how well air moves in the lungs of patients with various lung conditions, such as asthma, COPD, and pulmonary fibrosis. By using this technique, researchers hope to get more detailed insights into lung function and identify any areas where airflow might be blocked.

To take part in this study, participants need to be between 18 and 75 years old and have a diagnosed lung disease. They should be able to hold their breath for about 16 seconds and have stable health based on their medical history. However, people with certain conditions, like those who cannot have MRIs due to metal implants or who struggle with claustrophobia, will not be eligible. If someone joins the study, they will inhale a small amount of helium and then undergo an MRI scan. This trial is currently recruiting participants, so it’s a great opportunity for those who qualify to contribute to important research that could improve lung health understanding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects male and female aged 18-75 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, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP)
• • 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 in 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 \>0.5Liters
• Exclusion Criteria:
• • Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form.
• • Subject has a daytime room air oxygen saturation \<90% while lying supine.
• • Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
• • Subject previously injured by a metallic object that was not removed.
• • 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 implanted mechanically, electrically or magnetically activated 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.)