NCT02876731已完成不适用
Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
研究概览
简要总结
Prospective, monocentric, comparative, non randomised
Primary objective :
- to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional block and diffusion sequence in the search for bone metastases
Secondary objectives :
- compare accuracy of MRI diffusion and conventional MRI
- explore the evolution of the results of the different types of imaging over time or under treatment for patients with repeated examinations at 6 months
详细描述
Prospective, monocentric, comparative, non randomised.
Organization of NaF PET-CT and MRI on the same day or within a 10 days period.
At 6 months :
- repeat both exams systematically if one of the initial tests showed a suspicious or doubtful abnormality
- final diagnosis by a committee of practitioners using the whole patient's file
Scheduled Project inclusion duration of 36 months (possible adaptation of duration in order to obtain the number of required patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Man or woman over 18 years
- •Osteophilic cancer (breast, prostate, lung, kidney, thyroid) proved by pathological material, with a high probability of bone metastases
- •With an indication to a bone examination: systematic search for metastasis for the staging or due to clinical or laboratory suspicion of bone metastasis
- •Registered in a social security health scheme
- •Written informed consent obtained
排除标准
- •Classical contra-indications for PET CT (suspected pregnancy) or MRI (pacemaker, ferromagnetic material); for patients with a possibility of pregnancy (women of childbearing age without contraception and second part of the menstrual cycle, or the slightest suspicion), verification of the absence of pregnancy will be made by the beta HCG dosage before injection of radioactive tracer
- •Uncontrollable claustrophobia with treatment anxiolytic
- •Antitumor treatment started between the two imaging tests
- •Imaging or treatment needed in emergency, if both tests are not performable in time required for the care
- •Inaugural neurological complication
- •Patient unable to undergo biomedical research (under guardianship or deprived of liberty)
结局指标
主要结局
Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
时间窗: Up to 38 months
次要结局
未报告次要终点
研究者
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