NCT01291082Unknown不适用
Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Validation of whole body diffusion weighted MRI in breastcancer patients
研究概览
简要总结
Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.
详细描述
About 50 patients with a proven breast cancer and bone metastases will be included.
First step : staging
- nuclear bone scan
- Positron Emission Tomography (PET/CT)
- MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration
Aim :
- Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
- To calculate cut-off values for DWI for bone and visceral metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a proven breast cancer (by biopsy or imaging)
- •Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
- •Patient with an informed consent.
排除标准
- •Patients with a single bone metastasis treated by Radiotherapy will be excluded.
- •Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
- •Claustrophobia
- •Patient in a bad general condition.
结局指标
主要结局
Validation of whole body diffusion weighted MRI in breastcancer patients
时间窗: 6 months
whole body MRI will be correlated to the nucleair bone scan and PET-CT
次要结局
- Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment(12 months)
研究者
Steven Pans
Medical Doctor radiologist
Universitaire Ziekenhuizen KU Leuven
研究点 (1)
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