Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed
研究概览
简要总结
This is a single arm study in which patients will undergo MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) while receiving SOC RT for their soft tissue sarcoma.
详细描述
The purpose of this research is to determine if additional imaging during radiotherapy allows for better understanding of tumor's response to radiation and better treatment planning. Modern cancer treatment has used imaging to tailor individual patient treatment and to monitor responses to therapy. Typically, assessments of tumor response to radiation are conducted by repeat imaging after completing therapy. It is known that radiation can change aspects of the tumor which impact response to therapy. These changes can potentially be seen in imaging of the tumor. The researchers in this study believe that additional imaging during treatment will allow for more personalized and better treatment for sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients must have histologically or cytologically confirmed history of soft tissue sarcoma.
- •Plan to receive neoadjuvant radiation to a dose of 50 Gy in 25 fractions followed by surgical resection per Investigator.
- •Age ≥18 years.
- •ECOG performance status ≤2.
排除标准
- •Patients with Ewing's sarcoma and rhabdomyosarcoma.
- •Unable or unwilling to receive gadolinium-based contrast.
- •Patients who are unable or unwilling to undergo MRI studies.
- •Patients who may be unlikely or unable to be able to complete 3 additional MRI studies during the course of their 5-week radiation plan in the opinion of the PI.
结局指标
主要结局
Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed
时间窗: Treatment weeks 1, 3, and 5
1\. To evaluate the feasibility of completing serial MRI studies during a course of radiation. a. Feasibility will be measured as the percentage of study-specific MRI scans beyond standard of care which are completed at the end of the study with greater than or equal to a 66% completion rate overall (not per patient) being considered feasible.
次要结局
未报告次要终点
研究者
Andrew Frankart
Principal Investigator
University of Cincinnati