Ventilation Heterogeneity Prior to Lung Resection

NCT04191174 | Unknown

• 1 other identifier: FIRH_Xe004
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation

  Baseline

• 129Xe MRI ventilation heterogeneity and luminal cellular inflammation

  Baseline

• Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity

  up to 4 weeks

• Incidence of PPC: 129Xe MRI ventilation heterogeneity

  up to 4 weeks

• Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation

  up to 4 weeks

Other Outcomes (1)

• Correlation between ventilation heterogeneity quantified by Technegas V SPECT and 129Xe MRI

  Baseline

Study Arms (1)

Adults undergoing lung resection for lung cancer

Other: Hyperpolarized 129Xe MRI; Other: Technegas V SPECT; Other: Sputum Induction

Interventions

Hyperpolarized 129Xe MRI OTHER

Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity

Adults undergoing lung resection for lung cancer

Technegas V SPECT OTHER

Technegas V SPECT to evaluate ventilation heterogeneity

Adults undergoing lung resection for lung cancer

Sputum Induction OTHER

Sputum induction to evaluate luminal cellular inflammation

Adults undergoing lung resection for lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Cyclomedica Australia Pty Ltd: collaborator
• Ontario Lung Association: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related 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.

  PMID: 20805178 BACKGROUND

• 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.

  PMID: 26769017 BACKGROUND

• 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.

  PMID: 26008133 BACKGROUND

• 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.

  PMID: 24903918 BACKGROUND

• 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.

  PMID: 28603413 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Parameswaran Nair, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: January 6, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)