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Computed Tomography Assessment of Regional Ventilation (CURVE) (CURVE)

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ClinicalTrials.gov Identifier: NCT02879773
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
British Lung Foundation
Information provided by (Responsible Party):
Heart of England NHS Trust

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.

Condition or disease Intervention/treatment
Lung Neoplasms Emphysema Lung Diseases, Interstitial Pulmonary Disease, Chronic Obstructive Radiation: CTPVe

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 Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Non Contrast Computed Tomography in Assessment of Regional Ventilation of the Lung.
Study Start Date : February 2016
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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




Primary Outcome Measures :
  1. Percentage of eligible patients screened who consent to participate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Change in gas transfer [ Time Frame: 3-6 months ]
    Change in gas transfer factor (DLCO) reported as percentage of predicted value.

  2. Change in FEV1 [ Time Frame: 3-6 months ]
    Change in forced expiratory volume in 1 second reported as percentage of predicted value.

  3. Diagnosis [ Time Frame: 3-6 months ]
    The histological or multidisciplinary team consensus diagnosis of subtype of interstitial lung disease (if applicable)

  4. Change in perception of breathlessness [ Time Frame: 3-6 months ]
    Change in the patient perception of breathlessness measured suing Borg scale 0-10

  5. 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

  6. Percentage of patients who gave consent to participate but were later withdrawn [ Time Frame: 2 years ]
  7. Number of patients recruited per month [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879773


Contacts
Contact: Nicola Oswald, MBChB (+44)1214241895 nicola.oswald@heartofengland.nhs.uk
Contact: Amy Kerr (+44)1214241895 amy.kerr@heartofengland.nhs.uk

Locations
United Kingdom
Heart of England NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B95SS
Sponsors and Collaborators
Heart of England NHS Trust
British Lung Foundation
Investigators
Principal Investigator: Babu Naidu, MBBS Heart of England NHS Foundation Trust

Publications:
Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT02879773     History of Changes
Other Study ID Numbers: 178070
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Heart of England NHS Trust:
Respiratory Function Tests
Computed tomography
Thoracic surgical procedures
Diagnosis

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Emphysema
Lung Diseases, Interstitial
Lung Diseases, Obstructive
Chronic Disease
Lung Neoplasms
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms