Ventilation Heterogeneity Prior to Lung Resection

NCT ID: NCT04191174

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults undergoing lung resection for lung cancer

Hyperpolarized 129Xe MRI

Intervention Type OTHER

Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity

Technegas V SPECT

Intervention Type OTHER

Technegas V SPECT to evaluate ventilation heterogeneity

Sputum Induction

Intervention Type OTHER

Sputum induction to evaluate luminal cellular inflammation

Interventions

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Hyperpolarized 129Xe MRI

Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity

Intervention Type OTHER

Technegas V SPECT

Technegas V SPECT to evaluate ventilation heterogeneity

Intervention Type OTHER

Sputum Induction

Sputum induction to evaluate luminal cellular inflammation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyclomedica Australia Pty Ltd

UNKNOWN

Sponsor Role collaborator

Ontario Lung Association

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Parameswaran Nair, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20805178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26769017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26008133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24903918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28603413 (View on PubMed)

Other Identifiers

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FIRH_Xe004

Identifier Type: -

Identifier Source: org_study_id

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