Magnetic Resonance Imaging of the Whole Body, Including Diffusion, in the Medical Evaluation of Breast Cancers at High Risk for Metastasis and the Follow-up of Metastatic Cancers
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Apparent diffusion coefficient (ADC) (mm2/sec)
研究概览
简要总结
Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site.
Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.
Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.
详细描述
Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers.
Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site. Other sites include the lungs, liver, pleura, distant lymph nodes, soft tissue and the central nervous system.
Metastasis are located exclusively in the bones in 30% of the cases. The most commonly affected bones include the axial skeleton, rich in hematopoietic bone marrow : column, pelvis, skull, ribs, clavicles, the proximal part of the femur and humerus. Five percent of breast cancers are directly metastatic and 20 to 30% of localized breast cancers progress to metastatic stage. This potentially affects a large number of patients, with a median survival of 30 to 36 months.Patients with bone metastases only have a better survival rate than others: 20% at 5 years. It is therefore important to use a reliable and reproducible examination for the monitoring of treatment response.
Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk. However, this is a preliminary study with a limited and heterogeneous cohort of patients.
Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.
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
- •Histological diagnosis of breast carcinoma B5
- •Axillary lymph node punction C5 or metastatic
- •Performance status from 0 to 2.
排除标准
- •Ferromagnetic metallic foreign bodies (pacemakers, implanted cochlear, neurostimulator, ...)
- •Claustrophobia
结局指标
主要结局
Apparent diffusion coefficient (ADC) (mm2/sec)
时间窗: Once per year for a maximum of 2 years
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Number of cancer lesions
时间窗: Once per year for a maximum of 2 years
Exact localisation of cancer lesions
时间窗: Once per year for a maximum of 2 years
Systematic lecture grid. Possible choices are: Nodes (Axillary, internal mammary, supra and infraclavicular, cervical, mediastinal, hilar, upper abdomen, pelvic, inguinal), Bone (Spine, Scapular Belt, Costal Grill, Pelvic Belt)- Lungs and pleura - Liver (and other viscera)- Soft tissues and skin- Brain and spinal cord- Other
次要结局
未报告次要终点
研究者
Mieke Cannie
Head of clinic
Brugmann University Hospital
