Lung NeoplasmsCURVENCT02879773
Computed Tomography Assessment of Regional Ventilation (CURVE)
An observational study of Lung Neoplasms and Emphysema, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
This study uses CT scans to assess airflow in the lung, the scan is quick, cheap and painless. The information from the scan may help doctors tell which patients are suitable to have surgery to cure early stage lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Emphysema, Lung Diseases, Interstitial
- What is being tested?
- CTPVe
- Type of treatment
- Surgery or procedure
- How many people
- 131 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2016to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adults being assessed or treated in a hospital with a patient case mix and size typical of thoracic practice in England. As a tertiary referral centre patients will come from a wide geographical range and from both rural and urban settings.
Who may be able to join
- Patients aged 18 or over
- Undergoing assessment or treatment of parenchymal lung disease which involves CT scanning
- Able to understand the study information and provide written informed consent
Who cannot join
- Pregnancy
- Inability to follow breath hold instructions for CT scan
- Body size exceeding the capacity of CT scanner
- Previous chest wall resection
- Presence of implantable device that would cause artefacts on CT images including ICD, pacemaker, internal fixation of rib fracture, ventricular assist device, spinal rods/pedicle screws, shoulder replacement
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B95SS
About this study
Official title: An Observational Study of Non Contrast Computed Tomography in Assessment of Regional Ventilation of the Lung.
This study uses CT scans to assess airflow in the lung, the scan is quick, cheap and painless. The information from the scan may help doctors tell which patients are suitable to have surgery to cure early stage lung cancer. It may also help doctors tell which patients would benefit from surgery for emphysema and diagnose types of lung disease. The investigators will follow up patients who go through surgery to test how well the scan predicts the function of the lung after surgery. The investigators will follow patients being investigated for lung disease to test how accurate the scan is at the getting the diagnosis right.
Read the detailed description
CT scans during breathing in and breathing out (CTPVe) can assess regional airflow within the lung, using newly developed software as described by Aliverti et al. This provides information about the function of each part of the lung. The investigators aim to assess the feasibility of a larger trial using CTPVe to guide treatment of lung diseases and develop the statistical models needed for use in these trials.
Surgery provides the best prospect of a cure in early Non-small cell lung cancer. In the UK only half of people with early lung cancer undergo surgery and poor lung function may be a barrier to removal of part of the lung. Many patients with lung cancer also have emphysema or other lung diseases that reduce lung function. Actual post-operative lung function is often better predicted by current methods. The investigators will assess regional airflow in the lung and compare the airflow to the patients lung function both before and after surgery to assess if CTPVe can predict postoperative lung function, enabling more people to be considered suitable for curative surgery,
Severe emphysema is debilitating, some surgical treatments can improve the symptoms of emphysema; these include lung volume reduction surgery, endobronchial valves and endobronchial coils. Each of these are only suitable for certain patients and it is difficult to predict who will benefit most. The investigators will assess regional airflow in the lung and compare the airflow to the patients lung function before and after these treatments for emphysema to assess if CTPVe can predict who will benefit from surgery.
There are hundreds of subtypes of interstitial lung disease that respond to different types of treatment but diagnosing the subtype can be very difficult. Patients may need to undergo surgery to get the diagnosis of their subtype and this is associated with major risks, including death. The investigators will assess the regional airflow in the lung and compare the pattern to the final subtype of interstitial lung disease to assess if CTPVe could mean future patients do not need surgery for diagnosis.
- Conditions
- Lung Neoplasms, Emphysema, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
- Being tested
- CTPVe
- Keywords
- Respiratory Function Tests, Computed tomography, Thoracic surgical procedures, Diagnosis
- Medical subject headings
- Lung Neoplasms, Emphysema, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTPVeRadiation
Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Patients undergoing thoracic surgery for suspected or confirmed lung cancer; including wedge resection, segmentectomy, lobectomy, bilobectomy or pneumonectomy. CTPVe will be modelled to predict postoperative lung function. Receives: Radiation: CTPVe | |
| Emphysema | Patients undergoing assessment of emphysema/chronic obstructive pulmonary disease (COPD) for potential surgical intervention; including lung volume reduction surgery, endobronchial valve insertion or endobronchial coil insertion. CTPVe will be modelled to predict postoperative lung function. Receives: Radiation: CTPVe | |
| Interstitial lung disease | Patients undergoing assessment or treatment of suspected or confirmed interstitial lung disease. CTPVe will be modelled to aid diagnosis of the subtype of interstitial lung disease confirmed by histological diagnosis. Receives: Radiation: CTPVe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients screened who consent to participate
Measured: 2 years
Secondary outcomes (7)
Change in gas transfer
Change in gas transfer factor (DLCO) reported as percentage of predicted value.
Measured: 3-6 months
Change in FEV1
Change in forced expiratory volume in 1 second reported as percentage of predicted value.
Measured: 3-6 months
Diagnosis
The histological or multidisciplinary team consensus diagnosis of subtype of interstitial lung disease (if applicable)
Measured: 3-6 months
Change in perception of breathlessness
Change in the patient perception of breathlessness measured suing Borg scale 0-10
Measured: 3-6 months
Regional ventilation
Regional ventilation of the lung as assessed on CTPVe scanning, reported in millilitres of air per gram of lung tissue
Measured: 3-6 months
Percentage of patients who gave consent to participate but were later withdrawn
Measured: 2 years
Number of patients recruited per month
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start22 Jan 2016
- Primary completion1 Jun 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Lung Foundation
- Responsible party
- Sponsor
- Investigators
- Babu Naidu, MBBS, Principal investigator, Heart of England NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879773
- Sponsor's protocol ID
- 178070
- Acronym
- CURVE
- Status last verified
- Feb 2020
- First submitted
- 5 Aug 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aliverti A, Pennati F, Salito C, Woods JC. Regional lung function and heterogeneity of specific gas volume in healthy and emphysematous subjects. Eur Respir J. 2013 May;41(5):1179-88. doi: 10.1183/09031936.00050112. Epub 2012 Aug 9.
PubMed 22878884
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Non Contrast Computed Tomography in Assessment of Regional Ventilation of the Lung.
- ClinicalTrials.gov ID
- NCT02879773
- Acronym / sponsor ID
- CURVE / 178070
- Conditions
- Lung Neoplasms, Emphysema, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
- Keywords
- Respiratory Function Tests, Computed tomography, Thoracic surgical procedures, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Collaborators
- British Lung Foundation
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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 study uses CT scans to assess airflow in the lung, the scan is quick, cheap and painless. The information from the scan may help doctors tell which patients are suitable to have surgery to cure early stage lung cancer. It may also help doctors tell which patients would benefit from surgery for emphysema and diagnose types of lung disease. The investigators will follow up patients who go through surgery to test how well the scan predicts the function of the lung after surgery. The investigators will follow patients being investigated for lung disease to test how accurate the scan is at the getting the diagnosis right.
Detailed description
CT scans during breathing in and breathing out (CTPVe) can assess regional airflow within the lung, using newly developed software as described by Aliverti et al. This provides information about the function of each part of the lung. The investigators aim to assess the feasibility of a larger trial using CTPVe to guide treatment of lung diseases and develop the statistical models needed for use in these trials.
Surgery provides the best prospect of a cure in early Non-small cell lung cancer. In the UK only half of people with early lung cancer undergo surgery and poor lung function may be a barrier to removal of part of the lung. Many patients with lung cancer also have emphysema or other lung diseases that reduce lung function. Actual post-operative lung function is often better predicted by current methods. The investigators will assess regional airflow in the lung and compare the airflow to the patients lung function both before and after surgery to assess if CTPVe can predict postoperative lung function, enabling more people to be considered suitable for curative surgery,
Severe emphysema is debilitating, some surgical treatments can improve the symptoms of emphysema; these include lung volume reduction surgery, endobronchial valves and endobronchial coils. Each of these are only suitable for certain patients and it is difficult to predict who will benefit most. The investigators will assess regional airflow in the lung and compare the airflow to the patients lung function before and after these treatments for emphysema to assess if CTPVe can predict who will benefit from surgery.
There are hundreds of subtypes of interstitial lung disease that respond to different types of treatment but diagnosing the subtype can be very difficult. Patients may need to undergo surgery to get the diagnosis of their subtype and this is associated with major risks, including death. The investigators will assess the regional airflow in the lung and compare the pattern to the final subtype of interstitial lung disease to assess if CTPVe could mean future patients do not need surgery for diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Radiation: CTPVePatients undergoing thoracic surgery for suspected or confirmed lung cancer; including wedge resection, segmentectomy, lobectomy, bilobectomy or pneumonectomy. CTPVe will be modelled to predict postoperative lung function. |
| Emphysema | – | Radiation: CTPVePatients undergoing assessment of emphysema/chronic obstructive pulmonary disease (COPD) for potential surgical intervention; including lung volume reduction surgery, endobronchial valve insertion or endobronchial coil insertion. CTPVe will be modelled to predict postoperative lung function. |
| Interstitial lung disease | – | Radiation: CTPVePatients undergoing assessment or treatment of suspected or confirmed interstitial lung disease. CTPVe will be modelled to aid diagnosis of the subtype of interstitial lung disease confirmed by histological diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adults being assessed or treated in a hospital with a patient case mix and size typical of thoracic practice in England. As a tertiary referral centre patients will come from a wide geographical range and from both rural and urban settings.
Key inclusion criteria (3 listed)
- Patients aged 18 or over
- Undergoing assessment or treatment of parenchymal lung disease which involves CT scanning
- Able to understand the study information and provide written informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Inability to follow breath hold instructions for CT scan
- Body size exceeding the capacity of CT scanner
- Previous chest wall resection
- Presence of implantable device that would cause artefacts on CT images including ICD, pacemaker, internal fixation of rib fracture, ventricular assist device, spinal rods/pedicle screws, shoulder replacement
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 |
|---|---|---|
| CTPVeNon contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position | Radiation | Emphysema, Interstitial lung disease, Lung cancer |
Primary outcome
Percentage of eligible patients screened who consent to participate
Time frame: 2 years
7 secondary outcomes
Change in gas transfer
Time frame: 3-6 months
Change in FEV1
Time frame: 3-6 months
Diagnosis
Time frame: 3-6 months
Change in perception of breathlessness
Time frame: 3-6 months
Regional ventilation
Time frame: 3-6 months
Percentage of patients who gave consent to participate but were later withdrawn
Time frame: 2 years
Number of patients recruited per month
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 22878884Aliverti A, Pennati F, Salito C, Woods JC. Regional lung function and heterogeneity of specific gas volume in healthy and emphysematous subjects. Eur Respir J. 2013 May;41(5):1179-88. doi: 10.1183/09031936.00050112. Epub 2012 Aug 9.
- Individual participant dataSharing planned: Undecided
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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.
Babu Naidu, MBBS principal investigator
Heart of England NHS Foundation Trust
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 Neoplasms and Emphysema, run by Heart of England NHS Trust 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 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: finished, as of the sponsor's last update on 11 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of eligible patients screened who consent to participate (time frame: 2 years). 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 NCT02879773, which also lists 1 linked publication.
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 11 Feb 2020.