Single Pulmonary Nodule Investigation (SPUtNIk)
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 SPNs should undergo an initial fluorodeoxyglucose (FDG)-PET/CT scan, which may give more information about the SPN 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 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.
In this study the investigators propose to examine the diagnostic capacity of initially 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 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 SPN.
The investigators hope to recruit 375 people who have a SPN detected by a normal CT scan. These patients will normally be offered a FDG-PET/CT scan and if they participate in this study they will also receive a DCE-CT scan either on the same day or within two weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however patients will sign a consent form to give us permission to use data from any future CT scans or biopsies and any diagnosis that they may have over the next two years.
The study is coordinated by the clinical trials unit at Southampton University.
Recruitment began in January 2013. Patients will be recruited from 10 centres throughout the UK where they will be treated locally. The investigators expect recruitment to last until late 2014 and patient's medical data to be followed for another 2 years.
The investigators expect to have completed the analysis and made conclusions about the usefulness and cost effectiveness of DCE-CT scans in the diagnosis of early stage lung cancer in SPN.
The study is funded by the Health Technology Assessment arm of the National Institute for Health research, which is government funded.
Single Pulmonary Nodule
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules|
- Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer.
- cost effectiveness of using DCE-CT scans in the diagnosis of early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
- Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]Diagnostic test characteristics combined DCE-CT/18FDG-PET in relation to a subsequent clinical diagnosis of lung cancer.
- Effectiveness of using analysis of the CT image from the FDG-PET/CT in conjunction with data from the FDG incorporation to diagnose early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]Diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances in relation to a subsequent clinical diagnosis of lung cancer.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Indication: Lung Cancer
- To determine with high precision, the diagnostic performances of DCE-CT and 18FDG-PET/CT in the NHS for the characterisation of solitary pulmonary nodules (SPNs).
- To use decision analytic modelling to assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs.
- To assess, within an NHS setting, the incremental value of incorporating the CT appearances of a SPN into the interpretation of integrated PET/CT examinations.
- To assess whether combining DCE-CT with 18FDG-PET/CT is more accurate and/or cost-effective, in the characterisation of SPNs, than either test used alone or in series.
- To document the nature and incidence of incidental extra-thoracic findings on 18FDG-PET/CT undertaken for the characterisation of SPNs and model their impact on cost-effectiveness.
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN) on diagnostic imaging tests. This is an important group of patients because presentation as a SPN represents early disease with high 5 year survival rates following surgical resection. However, not all SPNs are due to lung cancer and the accurate characterisation of SPNs 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 SPNs recommend serial CT scans to look for subsequent growth with biopsy to confirm diagnosis. UK, National Institute for Health and Clinical Excellence (NICE) guidelines recommend 18FDG-PET for the assessment of SPN in cases where a biopsy is not possible or has failed.
DCE-CT and 18FDG-PET scans give different information about the SPN. Information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer.
Trial Design: Prospective Observational
Sample size: 375
Non-CTIMP:Non interventional trial
Concomitant Therapy: As per local practice
Primary Trial Endpoints:
Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer. The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
Secondary Trial Endpoints:
Secondary outcome measures will include diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances and combined DCE-CT/18FDG-PET. The incidence of incidental extra-thoracic findings on 18FDG-PET/CT, subsequent investigations and costs will also be determined.
Total Number of Sites: 10
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013063
|Contact: Jackie Dr Madden, PhD||00442380777222 ext email@example.com|
|Contact: Kelly Mrs Cozensfirstname.lastname@example.org|
|Southampton University Hospitals Nhs Trust||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator: Anindo Dr Banerjee, PhD|
|Aberdeen, United Kingdom, AB25 2ZN|
|Principal Investigator: Lutfi DR Kurban, MD|
|Brighton and Sussex University Hospitals Nhs Trust||Not yet recruiting|
|Brighton, United Kingdom, BN2 5BE|
|Principal Investigator: Sabina Dr Dizdarevic, MD|
|Papworth Hospital Nhs Foundation Trust||Recruiting|
|Cambridge, United Kingdom, CB23 3RE|
|Principal Investigator: Nagmi Dr Qureshi, M.B.|
|NHS Greater Glasgow and Clyde||Recruiting|
|Glasgow, United Kingdom, G116NT|
|Principal Investigator: Fat Wei Dr Poon, MBChB Medicine|
|Leeds Teaching Hospitals Nhs Trust||Not yet recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Principal Investigator: Mathhew Dr Callister, BM BCh MA PhD MEd|
|University College London Hospitals Nhs Foundation Trust||Recruiting|
|London, United Kingdom, NW1 2PG|
|Principal Investigator: Ashley Dr Groves, MBBS|
|University Hospital of South Manchester Nhs Foundation Trust||Not yet recruiting|
|Manchester, United Kingdom, M23 9LT|
|Principal Investigator: Philip Dr Crosbie, PhD|
|Principal Investigator:||Steve Dr George, MB BS, MD, MSC, FRCP||University of Southampton|