Single Pulmonary Nodule Investigation

Summary

A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.

This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN.

The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years.

The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018.

The study is funded by the NIHR-HTA

Conditions

• Malignant Neoplasm of Lung

Sponsors & Collaborators

• University of Southampton

  collaborator OTHER

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Papworth Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• East and North Hertfordshire NHS Trust

  collaborator OTHER_GOV

• NHS Grampian

  collaborator OTHER_GOV

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• Western Sussex Hospitals NHS Trust

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Steve George, MD,FRCP · University of Southampton

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2018-10-31

Completion

2018-10-31

Countries

• United Kingdom

Study Locations