Pilot Study: Dynamic Contrast-enhanced Magnetic Resonance Imaging(DCE-MRI)for Assessing Tumor Vascularity and Permeability in Soft Tissue Sarcoma Treated With Preoperative Radiotherapy Followed by Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
This is a pilot study to determine the diagnostic value of dynamic contrast enhancing MRI (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular permeability and microvessel density before and after preoperative radiotherapy.
详细描述
All patients have biopsy proven soft tissue sarcoma and undergo preoperative radiotherapy. Dynamic contrast-enhancing MRI T1-weight DCE-MRI will cover the whole tumor and involved lymph nodes if indicated. DCE-MRI is obtained before radiation starts and 4 weeks after RT completes. Blood volume images are estimated by using general Toft model, by which the blood flow was corrected for vascular permeability and perfusion. These images are geometrically co-registered with post-Gd T1-weighted MR images and pre-op RT routine MRI images are fused with the treatment planning CT.
Routine and DCE-MRI will be evaluated in each patient to determine the gross tumor volume. The quantitative parameters are determined on DCE-MRI for quantitative parameters in blood flow and permeability in the region of interest. Dynamic images are converted into color maps reflecting Ktrans, kep, Ve, and mean value of each parameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Pathologically confirmed soft tissue sarcoma.
- •Able to receive preoperative radiotherapy followed by surgical resection.
- •Able to provide treatment consent forms that conforms to federal and institutional guidelines.
- •Have adequate kidney function for safe administration of gadolinium contrast, as determined by current Department of Radiology MRI guidelines.
- •Creatinine clearance either by 24 hour collection or nomogram:
- •Creatinine clearance (CC) > 50 ml/min is determined by 24 hour collection or nomogram: CC male = (140 - age) x (wt. in kg)/(Serum Cr mg/dl) x 72 CC female = 0.85 x (CC male)
排除标准
- •Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which are contraindicated for MRI scan.
- •patients have pacemaker or defibrillator and contraindicated to MRI images
- •Patients are allergic to gadolinium IV contrast.
- •Patients have acute or chronic renal insufficiency and contraindicated to gadolinium contrast enhancing MRI.
- •Patient had previous radiation to the same disease site.
- •Patient had chemotherapy prior to preoperative radiotherapy.
- •Patients that are pregnant. Patients that may become pregnant must have a negative pregnancy test prior to enrolling.
结局指标
主要结局
Feasibility
时间窗: 36 months
Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma
次要结局
- Necrosis level(36 months)
- Tumor Volume change(36 months)