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Ventilation Heterogeneity Prior to Lung Resection

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04191174
Enrollment
115
Registered
2019-12-09
Start date
2020-01-06
Completion date
2024-12-01
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, lung resection, ventilation heterogeneity, Technegas V SPECT, hyperpolarized 129Xe MRI, airway inflammation

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.

Interventions

Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity

OTHERTechnegas V SPECT

Technegas V SPECT to evaluate ventilation heterogeneity

Sputum induction to evaluate luminal cellular inflammation

Sponsors

Cyclomedica Australia Pty Ltd
CollaboratorUNKNOWN
Ontario Lung Association
CollaboratorOTHER
St. Joseph's Healthcare Hamilton
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Abnormal ventilation heterogeneity assessed by 129Xe MRIBaselineProportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer.
Abnormal ventilation heterogeneity assessed by Technegas V SPECTBaselineProportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer.

Secondary

MeasureTime frameDescription
Technegas V SPECT ventilation heterogeneity and luminal cellular inflammationBaselineProportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by Technegas V SPECT.
Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneityup to 4 weeksDifference 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 inflammationup to 4 weeksDifference 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 inflammationup to 4 weeksDifference 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.
Incidence of PPC: 129Xe MRI ventilation heterogeneityup to 4 weeksDifference in incidence of PPC and related impact measures in preoperative ventilation heterogeneity normal and abnormal patients, assessed by 129Xe MRI.
129Xe MRI ventilation heterogeneity and luminal cellular inflammationBaselineProportion of patients with preoperative luminal cellular inflammation in the preoperative ventilation heterogeneity normal and abnormal groups, assessed by 129Xe MRI.

Other

MeasureTime frameDescription
Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRIBaselineUnivariate correlation between preoperative ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026