Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 入组人数
- 375
- 试验地点
- 9
- 主要终点
- Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN
研究概览
简要总结
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
详细描述
Indication: Lung Cancer
Primary Objectives:
- 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.
Secondary Objectives:
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤30mm on axial plane
- •Measured on lung window using conventional CT scan
- •No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion).
- •If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial.
- •Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent
- •Able and willing to consent to study
排除标准
- •Pregnancy
- •History of malignancy within the past 2 years
- •Confirmed aetiology of the nodule at the time of qualifying CT scan - As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to include is made on the analysis of the qualifying CT scan.
- •Biopsy of nodule prior to DCE-CT scan
- •Contra-indication to potential radiotherapy or surgery
- •Contra indication to scans (assessed by local procedures)
结局指标
主要结局
Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN
时间窗: 2 years
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
时间窗: 2 years
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.
次要结局
- 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(2 years)
- Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN(2 years)