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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Emphysema; Lung Diseases, Interstitial
• Intervention / Treatment: 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
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B95SS
      • Heart of England Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of eligible patients screened who consent to participate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gas transfer	Change in gas transfer factor (DLCO) reported as percentage of predicted value.	3-6 months
Change in FEV1	Change in forced expiratory volume in 1 second reported as percentage of predicted value.	3-6 months
Diagnosis	The histological or multidisciplinary team consensus diagnosis of subtype of interstitial lung disease (if applicable)	3-6 months
Change in perception of breathlessness	Change in the patient perception of breathlessness measured suing Borg scale 0-10	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	3-6 months
Percentage of patients who gave consent to participate but were later withdrawn		2 years
Number of patients recruited per month		2 years

Collaborators and Investigators

• Sponsor: Heart of England NHS Trust
• Collaborators: British Lung Foundation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Computed tomography; Diagnosis; Respiratory Function Tests; Thoracic surgical procedures
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Emphysema; Lung Diseases, Interstitial
• Other Study ID Numbers: 178070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided