PET/CT and Roentgen in Lung Cancer. Evaluation of Patients in General Practice
试验速览
- 阶段
- 4 期
- 入组人数
- 1,700
- 试验地点
- 3
- 主要终点
- Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer
研究概览
简要总结
The prognosis of lung cancer depends much on the stage of the disease at the time of diagnosis. Only 16 % of lung cancer can be offered curative intended surgery. Chest x-ray is the gate-keeper in lung cancer diagnosis, but it has a miss rate of 20-60 %. A false negative chest x-ray often causes prolonged delay in diagnosis - often months.
Recently a "48 hour diagnosis guaranty" has been implemented, which helps accelerate the system delay (delay from referral to diagnosis). But chest x-ray is still the gate-keeper; if the chest x-ray is negative further examination ceases.
PET/CT has a higher sensitivity (96 %), than chest x-ray. In the latter years only little improvement in the survival rate of lung cancer has been made. Screening studies is currently been performed, but it's time for innovative thinking. PET/CT has established its place in the staging of lung cancer. But studies like this may help to place PET/CT in the chain of examination making it more cost-beneficial.
The overall aim of this study is to improve patient course with earlier diagnosis of lung cancer.
详细描述
Background
Each year 3500 new patients in Denmark are diagnosed with lung cancer. This makes lung cancer the second most common cancer in Denmark. In Europe lung cancer is the most common cancer with an estimated 377 000 new cases each year. Lung cancer has a poor prognosis with a 5 year relative survival rate of approximately 10 % in Europe and 15 % in USA. The survival rate in Denmark has been inferior to that of other Nordic countries, partly because of unfavorable stage distribution at the time of diagnosis. Lately there has been an improvement in one year relative survival rate, because more patients are offered life prolonging chemotherapy, but with no influence on the 5-year survival rate.
The main investigation for suspected lung cancer is a chest x-rays, but chest x-rays has a miss rate of 20-60 %, which tends to delay the diagnosis by several months. Nodules < 1-1.6mm and centrally placed tumor increase the likelihood of a missed diagnosis.
Studies on screening for lung cancer has been promising, but has not yet shown an effect in terms of reduced mortality.
FDG-PET/CT is rapidly gaining acceptance in clinical oncology for diagnosing tumors, staging disease, and evaluating treatment response. PET/CT is a new scanner modality combinng the diagnostic accuracy of computed tomography (CT) with the metabolic activity recording of positron emission tomography (PET). A metaanalysis of PET alone has shown a sensitivity and specificity of 96 % and 78%, respectively with respect to diagnosis of pulmonary nodules. Studies with the combined PET/CT technique are expected to increase the specificity without affecting the high sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pt. referred from general practice to a chest x-ray
- •age 60-80 years
- •current or former smoker
排除标准
- •previously diagnosed with lung cancer
- •contraindications to PET/CT
结局指标
主要结局
Sensitivity and specificity of chest x-ray and PET/CT in Lung Cancer
时间窗: min. two years of follow up
次要结局
- Positive/negative predictive values of chest x-ray and PET/CT Operability - surrogate for survival Numbers of false positive PET/CT Numbers of false negative PET/CT Numbers of invasive procedures Cost-effectiveness(min. two years of follow-up)