NCT03151642已完成不适用
A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of MRIs
研究概览
简要总结
The purpose of this research study will be to determine the sensitivity and specificity of dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal cancer. This pilot study will generate the preliminary data needed for the design of a statistically-justified trial that would investigate dwMRI as an integral biomarker to stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a predictive clinical tool for a personalized treatment model that can identify patients who may be candidates for organ-preservation or treatment intensification to improve outcomes in esophageal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
- •Patients with AJCC 7th edition clinical stage IIB-IIIC
- •Patients will be treated with neoadjuvant chemoradiotherapy for this condition
- •Patients must be > 18 years of age
- •Patients must be able to provide informed consent
- •Patients must be surgical candidates
- •Patients must be able to tolerate MR imaging required by protocol
排除标准
- •Patients with primary tumors located above the carina
- •Prior abdominal radiation therapy with fields overlapping the current fields
- •Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice
- •Presence of MRI-incompatible metallic objects or implanted medical devices in the body (including but not limited to: non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, metal fragments in the eye or central nervous system)
- •Weight greater than that allowable by the MRI table
结局指标
主要结局
Number of MRIs
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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