Bronchial Thermoplasty for Severe Asthmatics Guided by HXe MRI

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2018

Study Completion Date

May 31, 2019

Conditions
Asthma
Interventions
DRUG

HXe MRI guided treatment sequence for BT

HXe MRI consists in imaging the inhaled xenon gas inside the human lungs during a short breath-hold. High resolution 3D maps of the HXe distribution inside the lungs provide information regarding ventilation of the lungs, as the signal is proportional to the local concentration of HXe. A high MRI signal translates in unobstructed ventilation, while ventilation defects appear as dark regions on the map. HXe MRI will be performed pre and post bronchodilator in order to determine the airways which potentially are the most responsive to BT treatment. All HXe MRI images will be repeated within the same day for consistency check and after three weeks to study temporal variability. The reactivity of the airways will establish the treatment order, with the most problematic airways to be treated in the first BT session (not to exceed six).

OTHER

Standard treatment sequence for BT (control)

Patients undergoing standard BT procedure will have HXe MRI performed at time intervals similar to HXe MRI guided BT patients. While HXe images will not be used for guiding the sequence for airways to receive the BT treatment, metrics extracted from HXe images will be compared with clinically accepted asthma severity metrics (spirometry and asthma questionnaires) to assess HXe MRI as a biomarker for asthma severity.

Trial Locations (1)

63110

Washington University in St. Louis, St Louis

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Washington University School of Medicine

OTHER

collaborator

University of Virginia

OTHER

lead

Xemed LLC

INDUSTRY

NCT01832363 - Bronchial Thermoplasty for Severe Asthmatics Guided by HXe MRI | Biotech Hunter | Biotech Hunter