Hyperpolarized Magnetic Resonance Imaging in Asthma Pre- and Post-Bronchial Thermoplasty

NCT02263794 | Completed

• 1 other identifier: ROB0039
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided or conventional bronchial thermoplasty using hyperpolarized noble gas imaging.

Conditions

Asthma

Keywords

Bronchial Thermoplasty

Outcome Measures

Primary Outcomes (1)

• Whole lung and lobe specific ventilation defect percent (VDP) as measured by 3He or 129Xe

  Change in VDP post BT

  48 +/- 2 weeks post bronchial thermoplasty treatment

Secondary Outcomes (3)

• Pulmonary function measurements

  48 +/- 2 weeks post bronchial thermoplasty

• Quality of Life questionnaires

  48 +/- 2 weeks post bronchial thermoplasty

• Dyspnea Scales

  48 +/- 2 weeks post bronchial thermoplasty

Study Arms (2)

Image guided bronchial thermoplasty

EXPERIMENTAL

At pre-treatment Visit 3, imaging data will be acquired to generate a patient-specific bronchial thermoplasty treatment plan which will include 15-20 target airways, prioritized in order of importance and grouped by lobe, to be targeted during a single session BT treatment procedure. Airways demonstrating dynamic or static bronchoconstriction will be targeted for BT treatment based on their spacial proximity to ventilation defects.

Procedure: Image Guided Bronchial Thermoplasty

Conventional bronchial thermoplasty

ACTIVE COMPARATOR

Patients in this group will undergo conventional 3 stage bronchial thermoplasty (during 3 separate bronchoscopies).

Procedure: Conventional Bronchial Thermoplasty

Interventions

Conventional Bronchial Thermoplasty PROCEDURE

Conventional bronchial thermoplasty is performed during three bronchoscopy sessions each separated by approximately three weeks.

Conventional bronchial thermoplasty

Image Guided Bronchial Thermoplasty PROCEDURE

Patient-specific bronchial thermoplasty based on imaging data will be performed during one bronchoscopy session.

Image guided bronchial thermoplasty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
• Male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
• Beta-agonist reversibility of FEV1\>12%, OR
• Methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving ICS or ≤ 16mg/ml if receiving an ICS.
• Subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
• Inhaled corticosteroid (ICS)
• Long-acting beta agonist (LABA)
• Other asthma medication such as leukotriene modifier, or anti-IgE, are acceptable
• FEV1 \> 50%pred pre-bronchodilator
• Subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
• Subject is a non-smoker for 1 year or greater (if former smoker less than 10 pack years total smoking history).
• Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
• Subject is judged to be in otherwise stable health on the basis of medical history

You may not qualify if:

• Subject 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 is unable to perform spirometry or plethysmography maneuvers
• Subject is pregnant
• Recent (within 4 weeks of BL Visit 1) or current asthma exacerbation and/or respiratory tract infection
• 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.) (At the discretion of the MRI Technologist/3T Manager)
• 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.

Sponsors & Collaborators

• Dr. Grace Parraga: lead
• McMaster University: collaborator

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

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

London, Ontario, N6A 5B7, Canada

Location

Related Publications (5)

• Svenningsen S, Kirby M, Starr D, Coxson HO, Paterson NA, McCormack DG, Parraga G. What are ventilation defects in asthma? Thorax. 2014 Jan;69(1):63-71. doi: 10.1136/thoraxjnl-2013-203711. Epub 2013 Aug 16.

  PMID: 23956019 BACKGROUND

• Janssen LJ. Airway smooth muscle as a target in asthma and the beneficial effects of bronchial thermoplasty. J Allergy (Cairo). 2012;2012:593784. doi: 10.1155/2012/593784. Epub 2012 Sep 16.

  PMID: 23024662 BACKGROUND

• Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.

  PMID: 17901415 BACKGROUND

• Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.

  PMID: 33289613 DERIVED

• Svenningsen S, Nair P, Guo F, McCormack DG, Parraga G. Is ventilation heterogeneity related to asthma control? Eur Respir J. 2016 Aug;48(2):370-9. doi: 10.1183/13993003.00393-2016. Epub 2016 May 12.

  PMID: 27174885 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

• David G McCormack, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

CA (2)