Bronchial Thermoplasty for Severe Asthmatics Guided by HXe MRI

Summary

The purpose of this study is to determine if the bronchial thermoplasty treatment can be guided through hyperpolarized xenon lung MRI.

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Washington University School of Medicine

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Xemed LLC

  lead INDUSTRY

Principal Investigators

• Iulian C Ruset, PhD · Xemed LLC

• James Quirk, PhD · Washington University School of Medicine

• Nicholas Tustison, PhD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2018-12-31

Completion

2019-05-31

Countries

• United States

Study Locations