NCT04041141撤回不适用
A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The volume of mandible irradiated to >55 Gy
研究概览
简要总结
The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving >55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices.
During radiation treatment patients will receive the standard oral stent device.
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
- •≥18 year old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively
- •Signed consent to study participation
- •No history of bleeding disorder
- •Platelets within normal limits (150-450 k/cumm)
排除标准
- •History of bleeding disorder
- •History of allergy to dental grade material
结局指标
主要结局
The volume of mandible irradiated to >55 Gy
时间窗: volume irradiated at Day 0
次要结局
- The position of the fiducial marker(Change in position at Day 0, Week 3, Week 5)
研究者
Mark Langer
Professor of Clinical Radiation Oncology
Indiana University
研究点 (1)
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