Ventilation Heterogeneity Prior to Lung Resection

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04191174
• Other study ID #: FIRH_Xe004
• Status: Enrolling by invitation
• Start date: January 6, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 115
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Hyperpolarized 129Xe MRI
Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity
• Technegas V SPECT
Technegas V SPECT to evaluate ventilation heterogeneity
• Sputum Induction
Sputum induction to evaluate luminal cellular inflammation

Locations

Country	Name	City	State
Canada	Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Cyclomedica Australia Pty Ltd, Ontario Lung Association, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123083. — View Citation

Bajc M, Chen Y, Wang J, Li XY, Shen WM, Wang CZ, Huang H, Lindqvist A, He XY. Identifying the heterogeneity of COPD by V/P SPECT: a new tool for improving the diagnosis of parenchymal defects and grading the severity of small airways disease. Int J Chron Obstruct Pulmon Dis. 2017 May 26;12:1579-1587. doi: 10.2147/COPD.S131847. eCollection 2017. — View Citation

Lugg ST, Agostini PJ, Tikka T, Kerr A, Adams K, Bishay E, Kalkat MS, Steyn RS, Rajesh PB, Thickett DR, Naidu B. Long-term impact of developing a postoperative pulmonary complication after lung surgery. Thorax. 2016 Feb;71(2):171-6. doi: 10.1136/thoraxjnl-2015-207697. — View Citation

Pike D, Kirby M, Guo F, McCormack DG, Parraga G. Ventilation heterogeneity in ex-smokers without airflow limitation. Acad Radiol. 2015 Aug;22(8):1068-78. doi: 10.1016/j.acra.2015.04.006. Epub 2015 May 23. — View Citation

Sheikh K, Paulin GA, Svenningsen S, Kirby M, Paterson NA, McCormack DG, Parraga G. Pulmonary ventilation defects in older never-smokers. J Appl Physiol (1985). 2014 Aug 1;117(3):297-306. doi: 10.1152/japplphysiol.00046.2014. Epub 2014 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI	Univariate correlation between preoperative ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI.	Baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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