Ventilation Heterogeneity Prior to Lung Resection

• Conditions: Lung Cancer
• Interventions: Other: Hyperpolarized 129Xe MRI; Other: Technegas V SPECT; Other: Sputum Induction

• Registration Number: NCT04191174
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2020-01-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults undergoing lung resection for lung cancer	Technegas V SPECT	-
Adults undergoing lung resection for lung cancer	Sputum Induction	-
Adults undergoing lung resection for lung cancer	Hyperpolarized 129Xe MRI	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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: 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.
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 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: 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.

Trial Locations

Locations (1)

Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada