Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
研究概览
简要总结
The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning.
Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method.
Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy
- •Age >18 years
- •Ability to understand and the willingness to sign a written informed consent document
- •Creatinine or creatinine clearance of <1.5 times the upper limit of normal or >45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level
排除标准
- •Patients who are currently receiving any investigational agents
- •Unable to undergo MRIs
- •Patients with late stage kidney disease or who have had a liver transplant
- •Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.
结局指标
主要结局
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
时间窗: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
次要结局
- Modeling the feasibility of the dose escalation using respiration induced anatomic changes(Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment))
研究者
Wensha Yang, PhD.
Assistant Professor
Cedars-Sinai Medical Center