Ventilation Heterogeneity Prior to Lung Resection

Study Overview
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Brief Summary
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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.

Official Title
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Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Hyperpolarized 129Xe MRI
* Other: Technegas V SPECT
* Other: Sputum Induction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults undergoing lung resection for lung cancer<br> | Other: Hyperpolarized 129Xe MRI<br>* Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity<br>Other: Technegas V SPECT<br>* Technegas V SPECT to evaluate ventilation heterogeneity<br>Other: Sputum Induction<br>* Sputum induction to evaluate luminal cellular inflammation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal ventilation heterogeneity assessed by Technegas V SPECT | Proportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer. | Baseline | 
| Abnormal ventilation heterogeneity assessed by 129Xe MRI | Proportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation | Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by Technegas V SPECT. | Baseline | 
| 129Xe MRI ventilation heterogeneity and luminal cellular inflammation | Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by 129Xe MRI. | Baseline | 
| Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity | Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity normal and abnormal patients, assessed by Technegas V SPECT | up to 4 weeks | 
| Incidence of PPC: 129Xe MRI ventilation heterogeneity | Difference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity normal and abnormal patients, assessed by 129Xe MRI. | up to 4 weeks | 
| Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation | 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. | up to 4 weeks | 
| Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation | 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. | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, lung resection, ventilation heterogeneity, Technegas V SPECT, hyperpolarized 129Xe MRI, airway inflammation