Lung CancerNCT04191174
Ventilation Heterogeneity Prior to Lung Resection
An observational study of Lung Cancer, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hyperpolarized 129Xe MRI, Technegas V SPECT and Sputum Induction
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2020to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing lung resection (at St. Joseph's Healthcare Hamilton) for lung cancer as part of their clinical care
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Firestone Institute for Respiratory Health, Research - St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
About this study
Official title: Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection
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
- Being tested
- Hyperpolarized 129Xe MRI, Technegas V SPECT, Sputum Induction
- Keywords
- lung cancer, lung resection, ventilation heterogeneity, Technegas V SPECT, hyperpolarized 129Xe MRI, airway inflammation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129Xe MRIOther
Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity
Technegas V SPECTOther
Technegas V SPECT to evaluate ventilation heterogeneity
Sputum InductionOther
Sputum induction to evaluate luminal cellular inflammation
| Study group | Role | What they receive |
|---|---|---|
| Adults undergoing lung resection for lung cancer | Not described Receives: Other: Hyperpolarized 129Xe MRI; Other: Technegas V SPECT; Other: Sputum Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: Baseline
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.
Measured: Baseline
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
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start6 Jan 2020
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Cyclomedica Australia Pty Ltd, Ontario Lung Association, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Parameswaran Nair, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191174
- Sponsor's protocol ID
- FIRH_Xe004
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20805178Lugg 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.
PubMed 26769017Pike 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.
PubMed 26008133Sheikh 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.
PubMed 24903918Bajc 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.
PubMed 28603413
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection
- ClinicalTrials.gov ID
- NCT04191174
- Acronym / sponsor ID
- FIRH_Xe004
- Conditions
- Lung Cancer
- Keywords
- lung cancer, lung resection, ventilation heterogeneity, Technegas V SPECT, hyperpolarized 129Xe MRI, airway inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Cyclomedica Australia Pty Ltd, Ontario Lung Association, St. Joseph's Healthcare Hamilton
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing lung resection for lung cancer | – | Other: Hyperpolarized 129Xe MRI, Other: Technegas V SPECT, Other: Sputum Induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing lung resection (at St. Joseph's Healthcare Hamilton) for lung cancer as part of their clinical care
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129Xe MRIHyperpolarized 129Xe MRI to evaluate ventilation heterogeneity | Other | Adults undergoing lung resection for lung cancer |
| Technegas V SPECTTechnegas V SPECT to evaluate ventilation heterogeneity | Other | Adults undergoing lung resection for lung cancer |
| Sputum InductionSputum induction to evaluate luminal cellular inflammation | Other | Adults undergoing lung resection for lung cancer |
Primary outcome
Abnormal ventilation heterogeneity assessed by Technegas V SPECT
Time frame: Baseline
Proportion of patients with abnormal ventilation heterogeneity, assessed by Technegas V SPECT, prior to lung resection for lung cancer.
Abnormal ventilation heterogeneity assessed by 129Xe MRI
Time frame: Baseline
Proportion of patients with abnormal ventilation heterogeneity, assessed by 129Xe MRI, prior to lung resection for lung cancer.
6 secondary outcomes
Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation
Time frame: Baseline
129Xe MRI ventilation heterogeneity and luminal cellular inflammation
Time frame: Baseline
Incidence of post-operative pulmonary complications (PPC): Technegas V SPECT ventilation heterogeneity
Time frame: up to 4 weeks
Incidence of PPC: 129Xe MRI ventilation heterogeneity
Time frame: up to 4 weeks
Incidence of PPC: Technegas V SPECT ventilation heterogeneity and luminal cellular inflammation
Time frame: up to 4 weeks
Incidence of PPC: 129Xe MRI ventilation heterogeneity and luminal cellular inflammation
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 20805178Agostini 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.
- Background: PubMed 26769017Lugg 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.
- Background: PubMed 26008133Pike 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.
- Background: PubMed 24903918Sheikh 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.
- Background: PubMed 28603413Bajc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parameswaran Nair, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal ventilation heterogeneity assessed by Technegas V SPECT (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191174, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.