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Ventilation Heterogeneity Prior to Lung Resection

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ClinicalTrials.gov Identifier: NCT04191174
Recruitment Status : Enrolling by invitation
First Posted : December 9, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Cyclomedica Australia Pty Ltd
Ontario Lung Association
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:
This is a single centre prospective six-week observational study to understand the prevalence and clinical relevance of abnormal ventilation of the lung (assessed by Technegas ventilation single photon emission computed tomography (V SPECT) and hyperpolarized 129Xe magnetic resonance imaging (MRI)), in the presence or absence of airway inflammation (assessed by sputum cell counts), in lung cancer patients prior to lung resection surgery.

Condition or disease Intervention/treatment
Lung Cancer Other: Hyperpolarized 129Xe MRI Other: Technegas V SPECT Other: Sputum Induction

Study Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Adults undergoing lung resection for lung cancer Other: Hyperpolarized 129Xe MRI
Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity

Other: Technegas V SPECT
Technegas V SPECT to evaluate ventilation heterogeneity

Other: Sputum Induction
Sputum induction to evaluate luminal cellular inflammation


Outcome Measures
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Primary Outcome Measures :
  1. Abnormal ventilation heterogeneity assessed by Technegas V SPECT [ Time Frame: Baseline ]
    Proportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer.

  2. Abnormal ventilation heterogeneity assessed by 129Xe MRI [ Time Frame: Baseline ]
    Proportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer.


Secondary Outcome Measures :
  1. Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation [ Time Frame: Baseline ]
    Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by Technegas V SPECT.

  2. 129Xe MRI ventilation heterogeneity and luminal cellular inflammation [ Time Frame: Baseline ]
    Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by 129Xe MRI.

  3. Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity [ Time Frame: up to 4 weeks ]
    Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity normal and abnormal patients, assessed by Technegas V SPECT

  4. Incidence of PPC: 129Xe MRI ventilation heterogeneity [ Time Frame: up to 4 weeks ]
    Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity normal and abnormal patients, assessed by 129Xe MRI.

  5. Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation [ Time Frame: up to 4 weeks ]
    Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity abnormal patients, assessed by Technegas V SPECT, with and without preoperative luminal cellular inflammation.

  6. Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation [ Time Frame: up to 4 weeks ]
    Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity abnormal patients, assessed by 129Xe MRI, with and without preoperative luminal cellular inflammation.


Other Outcome Measures:
  1. Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI [ Time Frame: Baseline ]
    Univariate correlation between preoperative ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing lung resection (at St. Joseph's Healthcare Hamilton) for lung cancer as part of their clinical care
Criteria

Inclusion Criteria:

  • Undergoing lung resection for lung cancer at St. Joseph's Healthcare (Hamilton, Ontario) in accordance with British Thoracic Society guidelines.
  • Males and females ≥ 18 years of age.
  • Able and willing to provide written informed consent.
  • Able and willing to comply with the study protocol.

Exclusion Criteria:

  • Previous lung resection surgery.
  • Previous chest radiation.
  • Patient 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.
  • 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.
  • Pregnancy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191174


Locations
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Canada, Ontario
Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
Cyclomedica Australia Pty Ltd
Ontario Lung Association
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Parameswaran Nair, MD, PhD McMaster University
More Information
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Publications:

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04191174    
Other Study ID Numbers: FIRH_Xe004
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
lung cancer
lung resection
ventilation heterogeneity
 Technegas V SPECT
hyperpolarized 129Xe MRI
airway inflammation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases