NCT02879773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

August 5, 2016

Last Update Submit

February 10, 2020

Conditions

Lung NeoplasmsEmphysemaLung Diseases, InterstitialPulmonary Disease, Chronic Obstructive

Keywords

Respiratory Function TestsComputed tomographyThoracic surgical proceduresDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of eligible patients screened who consent to participate

    2 years

Secondary Outcomes (7)

  • Change in gas transfer

    3-6 months

  • Change in FEV1

    3-6 months

  • Diagnosis

    3-6 months

  • Change in perception of breathlessness

    3-6 months

  • Regional ventilation

    3-6 months

  • +2 more secondary outcomes

Study Arms (3)

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

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

Interventions

CTPVeRADIATION

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

EmphysemaInterstitial lung diseaseLung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B95SS, United Kingdom

Location

Related 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.

    PMID: 22878884BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsEmphysemaLung Diseases, InterstitialPulmonary Disease, Chronic ObstructiveDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Study Officials

  • Babu Naidu, MBBS

    Heart of England NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 26, 2016

Study Start

January 22, 2016

Primary Completion

June 1, 2018

Study Completion

July 31, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

GB(1)