Preoperative Imaging in Retroperitoneal Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage
研究概览
简要总结
This is a prospective observational study in which patients with untreated retroperitoneal sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated with tumour pathology.
The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate assessment of tumour volume and local staging than CT and will identify areas of altered oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour shrinkage occurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.
排除标准
- •MRI incompatible metal implants
- •claustrophobia
结局指标
主要结局
Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage
时间窗: 2-4 weeks
Changes in volume, maximum axial diameter, ADC, F, D, D\*, T2, R2\* and enhancing fraction from baseline to post radiotherapy will be presented. A paired T-test (or Wilcoxon Signed Rank Test) may be used to test the difference between baseline and post radiotherapy. Differences in these values will be presented for responders and non-responders, which will be tested by independent T-test. Response will be determined by tumour size, enhancing fraction and histopathological evidence of response.
次要结局
- To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.(1-7 days)
研究者
Nandita deSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom