Lung CancerNCT03523611
Right Ventricular Inflammation After Lung Resection
An observational study of Lung Cancer and Ventricular Failure, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The purpose of this study is explore the impact of lung cancer surgery on inflammation and function of the right side of the heart. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Cancer, Ventricular Failure
- What is being tested?
- Lung Resection
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2018to 1 Aug 2019
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients undergoing lobectomy for primary lung cancer
Who may be able to join
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by VATS or open lobectomy
Who cannot join
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Wedge, segmental or sub-lobar lung resection
- Pneumonectomy
- Isolated right middle lobectomy
- Atrial fibrillation at baseline
Show all 14Show fewer
- Contraindication to cardiac magnetic resonance imaging
- Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant
- Aneurysm clips
- Metal injuries to the eye
- Loose metal in a part of the body
- Contraindication to IV Gadolinium (contrast) administration:
- Acute or chronic renal failure
- Allergy to contrast
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Golden Jubilee National Hospital
Glasgow, Strathclyde, G814HX
Emma Murphy, MBCHB, 7540221673, ezmurphy@doctors.org.uk
Ben Shelley, MbCHB
About this study
Official title: Cardiac Magnetic Resonance Assessment of Right Ventricular Inflammation After Lung Resection - a Feasibility Study
The purpose of this study is explore the impact of lung cancer surgery on inflammation and function of the right side of the heart.
Read the detailed description
Lung cancer is the second most common cancer in the UK and is the leading cause of cancer related death. Where appropriate, surgery to remove the tumour and the surrounding lung (lung resection) provides the best chance of cure. Frequently patients are either current or ex-smokers with related lung or heart problems which increase the risks associated with surgery. Following surgery patients may suffer long term shortness of breath, greatly limiting their day-to-day function and lowering quality of life. The investigators believe this shortness of breath is not solely caused by the removal of part of the lung but also from a decrease in the performance of the heart. Although the surgery does not directly involve the heart it is thought that the damage is caused indirectly by the surgery and by the removal of part of the lung.
In a previous study, the investigators showed that the function of the right side of the heart (the right heart) is decreased following lung resection. The decrease in right heart (the part that supplies blood to the lungs) function was associated with a prolonged stay in the high dependency unit and blood markers indicating damage to the heart. The process by which the damage occurs is poorly understood, but it is thought that an increase in the forces preventing the right heart pumping blood (resistance) is to blame. The decrease in function in the right heart may be triggered during surgery by the diminished blood supply to the cancerous lung and, and maintained post operatively, as lung resection can cause a long-term increase in resistance.
Diseases that cause an increase in resistance to the right heart have been shown to cause damage to different parts of the right heart. An acute sudden increase in resistance can cause inflammation, thinning and scarring whilst a long-term increase in resistance causes the right heart to thicken. The investigators believe that the potential damage during the operation could cause permanent damage to the right heart and contribute to shortness of breath and functional limitation.
To investigate the potential inflammation/scarring and the function of the heart the investigators will image the heart with specialised Magnetic Resonance Imaging (MRI) scans.
The aim of the research is to determine whether inflammation occurs in the right heart during and following lung resection and, if so, does it result in scarring?. The investigators will compare the function of the right heart before, during and after surgery to determine if inflammation contributes to the decrease in right heart function following lung resection seen in our previous study. The investigators anticipate that the study will increase understanding of how the right heart may be damaged by lung resection. The investigators believe this will guide further studies aiming to prevent such damage, ultimately limiting the disabling breathlessness and decrease in heart function that so greatly affects patients' lives.
- Conditions
- Lung Cancer, Ventricular Failure
- Being tested
- Lung Resection
- Keywords
- lung cancer, Ventricular Failure
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ResectionProcedure or surgery
Lung resection surgery
| Study group | Role | What they receive |
|---|---|---|
| lung resection | Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy Receives: Procedure: Lung Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can RV inflammation be assessed by T1 mapping CMR following lung resection by assessing the number of CMR studies which have an IQS>1?
The investigators will test and report inter- and intra-observer reproducibility of Region of Interest (ROI) definition in all datasets where Image Quality Score (IQS)>1. The primary endpoint will be the number of MRI studies which have an IQS >1.
Measured: 2 months
Secondary outcomes (3)
Are T1 values at the ventricular insertion points increased following lung resection?
In all patients, the investigators willl measure T1 values at the ventricular insertion points using ROI tool to determine if T1 is increased following lung resection.
Measured: 2 months
Association between RV inflammation and RV fibrosis following lung resection using measurement of extracellular volume?
Does the presence of RV inflammation ultimately lead to the development of RV fibrosis. In all patients, ECV will be assessed. An increase in ECV indicates development of fibrosis
Measured: 2 months
Is there any evidence of inflammation/fibrosis in the LV?
T1 values will be assessed in all patients at the LV free wall using ROI tool. ECV at the LV free wall will be measured to determine if there is fibrosis present.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start30 Apr 2018
- Primary completion19 Apr 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ben Shelley, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523611
- Sponsor's protocol ID
- 17/ANAES/06
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Assessment of Right Ventricular Inflammation After Lung Resection - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03523611
- Acronym / sponsor ID
- 17/ANAES/06
- Conditions
- Lung Cancer, Ventricular Failure
- Keywords
- lung cancer, Ventricular Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 19 Apr 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 14 May 2018 (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.
The purpose of this study is explore the impact of lung cancer surgery on inflammation and function of the right side of the heart.
Detailed description
Lung cancer is the second most common cancer in the UK and is the leading cause of cancer related death. Where appropriate, surgery to remove the tumour and the surrounding lung (lung resection) provides the best chance of cure. Frequently patients are either current or ex-smokers with related lung or heart problems which increase the risks associated with surgery. Following surgery patients may suffer long term shortness of breath, greatly limiting their day-to-day function and lowering quality of life. The investigators believe this shortness of breath is not solely caused by the removal of part of the lung but also from a decrease in the performance of the heart. Although the surgery does not directly involve the heart it is thought that the damage is caused indirectly by the surgery and by the removal of part of the lung.
In a previous study, the investigators showed that the function of the right side of the heart (the right heart) is decreased following lung resection. The decrease in right heart (the part that supplies blood to the lungs) function was associated with a prolonged stay in the high dependency unit and blood markers indicating damage to the heart. The process by which the damage occurs is poorly understood, but it is thought that an increase in the forces preventing the right heart pumping blood (resistance) is to blame. The decrease in function in the right heart may be triggered during surgery by the diminished blood supply to the cancerous lung and, and maintained post operatively, as lung resection can cause a long-term increase in resistance.
Diseases that cause an increase in resistance to the right heart have been shown to cause damage to different parts of the right heart. An acute sudden increase in resistance can cause inflammation, thinning and scarring whilst a long-term increase in resistance causes the right heart to thicken. The investigators believe that the potential damage during the operation could cause permanent damage to the right heart and contribute to shortness of breath and functional limitation.
To investigate the potential inflammation/scarring and the function of the heart the investigators will image the heart with specialised Magnetic Resonance Imaging (MRI) scans.
The aim of the research is to determine whether inflammation occurs in the right heart during and following lung resection and, if so, does it result in scarring?. The investigators will compare the function of the right heart before, during and after surgery to determine if inflammation contributes to the decrease in right heart function following lung resection seen in our previous study. The investigators anticipate that the study will increase understanding of how the right heart may be damaged by lung resection. The investigators believe this will guide further studies aiming to prevent such damage, ultimately limiting the disabling breathlessness and decrease in heart function that so greatly affects patients' lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung resection | – | Procedure: Lung ResectionPatients with suspected lung cancer undergoing lung resection by anatomic lobectomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing lobectomy for primary lung cancer
Key inclusion criteria (3 listed)
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by VATS or open lobectomy
Key exclusion criteria (14 listed)
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Wedge, segmental or sub-lobar lung resection
- Pneumonectomy
- Isolated right middle lobectomy
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 |
|---|---|---|
| Lung ResectionLung resection surgery | Procedure or surgery | lung resection |
Primary outcome
Can RV inflammation be assessed by T1 mapping CMR following lung resection by assessing the number of CMR studies which have an IQS>1?
Time frame: 2 months
The investigators will test and report inter- and intra-observer reproducibility of Region of Interest (ROI) definition in all datasets where Image Quality Score (IQS)>1. The primary endpoint will be the number of MRI studies which have an IQS >1.
3 secondary outcomes
Are T1 values at the ventricular insertion points increased following lung resection?
Time frame: 2 months
Association between RV inflammation and RV fibrosis following lung resection using measurement of extracellular volume?
Time frame: 2 months
Is there any evidence of inflammation/fibrosis in the LV?
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- 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.
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 and Ventricular Failure, run by University of Glasgow at 1 site in United Kingdom.
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 3 inclusion and 14 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 29 May 2018. 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can RV inflammation be assessed by T1 mapping CMR following lung resection by assessing the number of CMR studies which have an IQS>1? (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2018.