Computed Tomography Assessment of Regional Ventilation (CURVE)

ID: NCT02879773
Status: Recruiting
Phase: N/A
Start Date: February 01, 2016
First Submitted: August 05, 2016
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Heart of England NHS Trust, British Lung Foundation
Location: United Kingdom
Conditions: Lung Neoplasms, Emphysema, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
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Study Description

Brief 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. 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.
Condition or disease Intervention/treatment Phase

Emphysema

Lung Diseases, Interstitial

Lung Neoplasms

Pulmonary Disease, Chronic Obstructive

Radiation: CTPVe
Other Names
N/A

Tracking Information

First Submitted DateAugust 05, 2016
Last Update Posted DateFebruary 23, 2018
Start DateFebruary 01, 2016
Anticipated Completion DateApril 01, 2018
Primary Completion DateApril 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of eligible patients screened who consent to participate [Time Frame: 2 years]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change in gas transfer [Time Frame: 3-6 months]

    Change in gas transfer factor (DLCO) reported as percentage of predicted value.

  • Change in FEV1 [Time Frame: 3-6 months]

    Change in forced expiratory volume in 1 second reported as percentage of predicted value.

  • Diagnosis [Time Frame: 3-6 months]

    The histological or multidisciplinary team consensus diagnosis of subtype of interstitial lung disease (if applicable)

  • Change in perception of breathlessness [Time Frame: 3-6 months]

    Change in the patient perception of breathlessness measured suing Borg scale 0-10

  • Regional ventilation [Time Frame: 3-6 months]

    Regional ventilation of the lung as assessed on CTPVe scanning, reported in millilitres of air per gram of lung tissue

  • 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComputed Tomography Assessment of Regional Ventilation (CURVE)
Official TitleAn Observational Study of Non Contrast Computed Tomography in Assessment of Regional Ventilation of the Lung.
Brief 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. 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 TypeObservational
Study PhaseN/A
Estimated Enrollment
132
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Emphysema
Lung Diseases, Interstitial
Lung Neoplasms
Pulmonary Disease, Chronic Obstructive
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationThe 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.
Intervention
Radiation: CTPVe

Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position

Other Names
Study Groups/Cohorts
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.

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.

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.

Study Arms
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.
Radiation : CTPVe
Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position

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.
Radiation : CTPVe
Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position

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.
Radiation : CTPVe
Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position

Arm Intervention/Treatment
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.
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.
Radiation : CTPVe
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.
Radiation : CTPVe

Recruitment Information

Recruitment Status:Recruiting
Enrollment132
Completion DateApril 01, 2018
Eligibility Criteria: Inclusion Criteria:
- 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

Exclusion Criteria:
- 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United Kingdom

Administrative Information

NCT Number:NCT02879773
Other Study ID Numbers
178070
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Heart of England NHS Trust
Collaborators
British Lung Foundation
Investigators
Principal Investigator
Babu Naidu, MBBS
Heart of England NHS Foundation Trust