Clinical trial NCT04191174: Ventilation Heterogeneity Prior to Lung Resection
Official title: Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Cancer
Keywords: lung cancer
lung resection
ventilation heterogeneity
Technegas V SPECT
hyperpolarized 129Xe MRI
airway inflammation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Cyclomedica Australia Pty Ltd
name: Ontario Lung Association
name: St. Joseph's Healthcare Hamilton
First posted: 2019-12-09
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing lung resection (at St. Joseph's Healthcare Hamilton) for lung cancer as part of their clinical care

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abnormal ventilation heterogeneity assessed by Technegas V SPECT
timeFrame: Baseline
measure: Abnormal ventilation heterogeneity assessed by 129Xe MRI
timeFrame: Baseline
Secondary outcomes:
measure: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation
timeFrame: Baseline
measure: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation
timeFrame: Baseline
measure: Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity
timeFrame: up to 4 weeks
measure: Incidence of PPC: 129Xe MRI ventilation heterogeneity
timeFrame: up to 4 weeks
measure: Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation
timeFrame: up to 4 weeks
measure: Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation
timeFrame: up to 4 weeks
Other outcomes:
measure: Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI
timeFrame: Baseline
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Parameswaran Nair, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.