Characterization of Physiological and Morphological Features of Clinical Head & Neck Squamous Cell Carcinomas (HNSCCs) Using a Quantitative Optical Sensor
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis.
研究概览
简要总结
The goal of this study is to determine the optical spectroscopy characteristics of tumor in patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of all head and neck cancers. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. These readings will be performed in the operating room during routine endoscopy with biopsy and tumor mapping of patients who have a suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure sensor will be used to compare biopsy sites with their benign counterparts. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with unknown primaries in which numerous directed biopsies are obtained from multiple head and neck sites.
详细描述
PURPOSE OF THE STUDY:
HYPOTHESES:
Noninvasive optical spectroscopic measurements of Head and Neck Squamous Cell Carcinoma (HNSCC) result in unique signatures that can differentiate between dysplasia, normal, other benign conditions as well as response to radiation therapy as assessed by clinical and histopathological methods.
STUDY OBJECTIVES
- Characterization of physiological and morphological features of clinical HNSCCs using a spectroscopy based quantitative optical sensor
- Evaluate the built-in pressure sensor of the probe as a means of making more measurements at a more consistent, narrower pressure range.
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
- 24 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing panendoscopy and biopsy for suspected squamous cell carcinoma of the head and neck.
- •patient is > 24 to <89 years of age
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •< 24 years of age, >89 years of age
- •Unable to provide written informed consent.
结局指标
主要结局
Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis.
时间窗: During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
次要结局
- Optimal pressure levels of the optical probe(During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements)
- Added pressure sensing and self-calibration features of the optical probe improves specificity and sensitivity to differentiate HNSCC from their benign counterparts(During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements)