Ventilation Heterogeneity Prior to Lung Resection

Sponsor

McMaster University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04191174

Collaborator

Cyclomedica Australia Pty Ltd (Other), Ontario Lung Association (Other), St. Joseph's Healthcare Hamilton (Other)

115

Enrollment

Location

29.8

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Lung Cancer	Other: Hyperpolarized 129Xe MRI Other: Technegas V SPECT Other: Sputum Induction

Study Design

Study Type:

Observational

Anticipated 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 :

Jan 6, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Abnormal ventilation heterogeneity assessed by Technegas V SPECT [Baseline]
Proportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer.
Abnormal ventilation heterogeneity assessed by 129Xe MRI [Baseline]
Proportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer.

Secondary Outcome Measures

Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation [Baseline]
Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by Technegas V SPECT.
129Xe MRI ventilation heterogeneity and luminal cellular inflammation [Baseline]
Proportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by 129Xe MRI.
Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity [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
Incidence of PPC: 129Xe MRI ventilation heterogeneity [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.
Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation [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.
Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation [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

Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI [Baseline]
Univariate correlation between preoperative ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.