Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Percent Change in Total Mean Clinical Target Volumes (CTV) Between the Standard of Care Treatment Plan and the Treatment Plan Based on the TraceIT Hydrogel Markers
研究概览
简要总结
The purpose of this research study is to look at how using an injectable marker called TraceIT can help with the radiation treatment planning process. TraceIT is a gel that dissolves in the body over time and can be injected and is visible on many types of images that can be used in the treatment planning process. If the exact edges of negative tumor margins can be marked before treatment planning, it is thought that the area receiving radiation can be more personalized, thus potentially reducing unnecessary radiation to areas that are cancer-free.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 (by routine H&E staining) or highly suspicious for oropharyngeal squamous cell cancer.
- •Planned treatment includes transoral surgery followed by adjuvant intensity modulated radiation therapy (IMRT).
- •At least 18 years of age.
- •Ability to understand and willingness to sign an IRB approved written informed consent document.
排除标准
- •Distant metastatic disease at the time of definitive treatment, and thus study, initiation.
- •History of major head & neck surgery or previous head & neck irradiation.
- •History of or current oral disease that may interfere with interpretation of study outcomes.
- •Currently enrolled in another radiation therapy trial that has not completed its primary endpoint or that clinically interferes with this study.
- •Poor surgical candidate
- •Prisoners
结局指标
主要结局
Percent Change in Total Mean Clinical Target Volumes (CTV) Between the Standard of Care Treatment Plan and the Treatment Plan Based on the TraceIT Hydrogel Markers
时间窗: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
-The mean total dose of each targeted site was totaled from the standard of care treatment plan and the TraceIT tissue marker treatment plan. The percent change in CTV was measured by standard field in cGy minus marker based in cGy = percent change in CTV (in cGy). The sites included left \& right submandibular, left \& right parotid, left \& right pharynx constrictor, oral cavity, lips, larynx, and spinal cord.
次要结局
- Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection(From time of injection through surgery (day 1))
- Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible(At the treatment planning (2-5 weeks after TraceIT hydrogel placement))