Computed Tomography Assessment of Regional Ventilation (CURVE)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— CURVE  

Official title:

An Observational Study of Non Contrast Computed Tomography in Assessment of Regional Ventilation of the Lung.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879773
• Other study ID #: 178070
• Status: Completed
• Start date: January 22, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2020
• Source: Heart of England NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 31, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Foundation Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Heart of England NHS Trust	British Lung Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

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