Title: Accuracy and cost-effectiveness of dynamic contrast enhanced computed tomography in the characterisation of solitary pulmonary nodules.
Funder: Department of Health and Social Care

Abstract: A proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN) on diagnostic imaging tests. This is an important group because presentation as a SPN represents early disease with high 5 year survival rates. However, not all single nodules are malignant and the accurate characterisation of single nodules for diagnosis of early stage lung cancer is a diagnostic challenge with significant associated health costs. Widely adopted clinical guidelines for the subsequent investigation of solitary pulmonary nodules, recommend serial CT scans to monitor subsequent growth with biopsy to confirm diagnosis. National Institute for Health and Clinical Excellence (NICE) guidelines recommend FDG-PET for the assessment of single nodules in cases where a biopsy is not possible or has failed. DCE-CT and FDG-PET scans give different information about the nodule. Information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. We will undertake a clinical trial primarily to determine the diagnostic performances of DCE-CT and FDG-PET/CT in the characterisation of solitary pulmonary nodules. In parallel we will undertake a systematic review and meta-analysis to evaluate the accuracy and cost effectiveness of FDG-PET/CT and DCE-CT in the diagnosis of single nodes. The results will inform an analytical model to assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with solitary pulmonary nodes, which will be applied to the clinical trial results. Secondary objectives are to assess, within an NHS setting, the incremental value of incorporating the CT appearances of the node into the interpretation of integrated PET/CT examinations, to assess whether combining DCE-CT with FDG-PET/CT is more accurate and/or cost-effective, in the characterisation of pulmonary nodes and to document the nature and incidence of incidental extra-thoracic findings on FDG-PET/CT undertaken for the characterisation of SPNs and model their impact on cost-effectiveness.

Lay abstract: A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN), this is a single spot on a CT scan. 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 patients should undergo an initial FDG-PET/CT scan, which may give more information about the nodule and may indicate that it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the nodule with a series of CT scans over 2 years to look for changes or growth which may/ but do not always indicate lung cancer. If no changes are observed over 2 years the nodule is considered not to be lung cancer. This is both expensive for the NHS and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis. In this study we propose to examine the diagnostic capacity of initially using a different CT scan (DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the nodule and we 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. We will also undertake a review of previous studies that have been done using these scans in the diagnosis of lung cancer and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of solitary pulmonary nodules.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS