Neoadjuvant Radiotherapy of Soft Tissue Sarcomas of Limbs and Trunk : Interest of Multiparametric Quantitative MRI for Response Assessment and Per-treatment Progression Prediction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Maximum axial dimension
研究概览
简要总结
This trial is a prospective, monocentric, with minimal risks and constraints study, conducted in patients with Soft Tissue Sarcoma (STS) of the limbs and trunk with indication for neoadjuvant radiotherapy (RT).
Patients will be treated by neoadjuvant RT and will have a pre-RT and a post-RT multiparametric quantitative Magnetic Resonance Imaging (MRI).
A tumor resection will be performed 6 to 8 weeks post-RT and an anatomopathological observation of the surgical specimen will be performed.
This study will allow to describe the initial remnographic characteristics and their evolution after neoadjuvant RT using quantitative multiparametric MRI (mpMRI).
详细描述
This study is prospective, monocentric and with minimal risks and constraints.
Patients with STS of the limbs and trunk will be accrued during the initial radiotherapy consultation radiotherapy (prior to receiving radiotherapy).
Two quantitative multiparametric MRI will be performed. The first one will be acquired less than 14 days before the dosimetric scan, the second one 4 to 6 weeks after the end of the radiotherapy.
This study will allow to describe the initial remnographic characteristics and their evolution after neoadjuvant RT using quantitative multiparametric MRI.
STATISTICAL ANALYSIS
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum axial dimension
时间窗: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the maximum axial dimension (mm) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Volume of the region of interest (ROI)
时间窗: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the volume of the region of interest (ROI) (mm3) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Minimum, maximum, mean, median, 10th, 25th, 75th and 90th percentile values of free diffusion (D) and microperfusion-related diffusion (D*).
时间窗: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the minimum, maximum, mean, median, 10th, 25th, 75th and 90th percentile values of free diffusion (D) and microperfusion-related diffusion (D\*) (mm2/s) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
Fraction of perfusion (f)
时间窗: Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Post-radiotherapy mpMRI performed 4 to 6 weeks after radiation therapy completion.
Evolution of the fraction of perfusion (f) after neoadjuvant radiotherapy, obtained with quantitative multiparametric MRI
次要结局
- Predictive biomarker of complete pathological response in pre-radiotherapy mpMRI(Pre-radiotherapy mpMRI performed within 14 days before the dosimetric scan. Surgery performed 6 to 8 weeks after radiation therapy completion.)