The Value of Early PET/CT in Patients With Metastasising Cancer of Unknown Primary
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- 1. Detection of primary tumor possible: yes/no (primary endpoint)
研究概览
简要总结
The purpose is to elucidate the value of PET/CT applied early in the work-up of patients with a metastasising cancer of an unknown primary tumor.
The management of patients with metastasising cancer of unknown primary often includes various and a large number of radiographic studies and invasive procedures, but the occult primary tumor is detected in less than 20%.
Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive diagnostic procedures are carried out. The outcome may be higher tumor detection rate and quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number of the patients will receive treatment aimed at the correct diagnosis. Therefore, a prospective cost-effectiveness analysis is warranted.
详细描述
Background:
Every year, 800-1000 patients in Denmark are classified with a diagnosis of metastasising cancer of unknown primary (CUP). This corresponds to approximately 3 % percent of all new cancer cases on a national scale. The number is probably higher, since this is a heterogeneous group of patients that is not registered consistently. The prognosis is poor; the average survival is only approximately one year.
CUP is characterized by the finding of a metastasis the starting point of which (the primary tumour) is unknown. Typically, one finds an enlarged lymph node in the neck, a swelling in the throat or in the stomach, a filling in the skin or a tumour detected somewhere in the body during an X-Ray examination, an endoscopy or the like. In spite of a search applying multiple techniques, the primary tumour remains unknown in 70-80% of the patients.
A great number of patients experience a long and discontinuous examination sequence marked by various contacts with doctors, many examinations dispersed over many days and locations, as well as a lot of time wasted, because there exists no single option or institution that takes care of the patient and handles diagnostic procedures and treatment efficiently.
Treatment is often initiated too late, typically as a combination of several chemotherapeutics in order to cover different types of cancer simultaneously, but modern chemotherapeutical regimes have not increased the survival rate. The bad prognosis is undoubtedly due to the fact that the patients are diagnosed in an advanced phase. Alternatively, the primary tumour is not detected at all. This, in part, is due to the absence of any single agency in possession of the competence and responsibility to implement the work-up without delay, and maybe because one does not offer examination by the modality (PET/CT) which is most likely to detect the presence of cancer, its starting point and dispersion in an early stage.
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 (Investigator)
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
- •Biopsy proven cancer without identified origin at the time of examination.
- •Patients admitted to but not fitting into existing cancer package programs.
- •Patients with very serious, but unknown, disease, which might be cancer.
排除标准
- •Patient belongs to one of the existing cancer packages - state which one.
- •Suspected metastasis in the liver.
- •Suspected metastasis in the brain.
- •Prior PET/CT imaging showing multiple metastases with no identifiable primary.
- •Cancer treatment already started.
- •Estimated inability to collaborate - state reason.
- •Prior malignant disease.
- •The patient cannot read and understand Danish.
结局指标
主要结局
1. Detection of primary tumor possible: yes/no (primary endpoint)
时间窗: Up to 24 hours
The outcome is evaluated based on the project specified PET/CT compared to conventional diagnostic investigations including CT. - The evaluation of the PET/CT scan, primary tumor/non-primary tumor, is obtained by consensus of two nuclear medicine physicians with experience in PET/CT.
次要结局
- 2. Time frame from inclusion into the study to detection of primary tumor.(Up to 1 week)
- 3. Time frame from inclusion into the study to referral to palliative or curative treatment.(Up to 4 weeks)
- 4. Time frame from inclusion into the study to end of follow-up or death.(36 months)
- 5. Total score of Quality of Life instrument "SF-36".(36 months)
研究者
Charlotte Krogh Rask
Medical doctor
Odense University Hospital
