Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- ThatPET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5 year survival, cost and time to identification of new disease
研究概览
简要总结
This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with PET/CT only, over a five year period. The purpose is to show through utilization of the single most sensitive and specific test currently available-PET/CT-that survival for patients in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence and compliance with follow-up appointments).
详细描述
Routine visits would include COLON:14 visits with cea and 6 CTs over a 5 year period plus PET/CT at last visit RECTAL: 14 visits with cea and 6 CTs and 4 procto exams over 5 year period plus PET/CT at last visit HEAD/NECK: 14 visits with 4 CTs and PET/CT at last visit LUNG:12 visits plus 4 CTs and PET/CT at last visit
Limited follow-up ALL GROUPS: a history and physical plus PET/CT at 3 month, 9 month, 18 month, 36 month and 60 month only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed primary therapy such that no disease is evident at the time of enrollment in the study
排除标准
- •Patients unable to consent
- •Without diagnosis of colorectal cancer
- •Non-small cell lung cancer or squamous cell cancer of the head and neck
- •Unwilling or unable to participate in the assigned follow-up program
- •Having a serum glucose at time of PET/CT greater than 180mg/dl
- •Stage IV disease or with evidence of disease recurrence post treatment
- •Who are not a candidate for further treatment should a recurrence of disease be identified
结局指标
主要结局
ThatPET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5 year survival, cost and time to identification of new disease
时间窗: 5 years
次要结局
- Improvement in patient/caregiver compliance in keeping their appointments and completing their tests(5 years)