Non-Invasive Optical Spectroscopy for Identification of Cutaneous Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue.
研究概览
简要总结
- Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner.
- Study activities and population group: Competent adults with a clinically suspicious skin lesion who are undergoing a biopsy as part of their routine care. For those who agree to participate, the sterilized portable optical spectroscopic probe will be used to measure diffuse reflectance on the lesion of clinical interest.
- Data analysis and risk/safety issues: The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis. A variety of correlative statistics will be explored to determine if there are relationships found that can justify a larger study
详细描述
This is a pilot study to determine the optical spectroscopy characteristics of tumor in patients with cutaneous malignancies. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. 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 numerous suspicious skin lesions who would require multiple biopsies.
Further spectroscopy measurements of the tumor site and adjacent normal tissue during therapy (chemoradiotherapy or radiotherapy) may provide useful information pertinent to tumor physiology and therapeutic effectiveness.
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 at least one clinically suspicious skin lesion warranting a biopsy as part of routine care, in the outpatient clinic setting.
- •Patients with previous histologically confirmed malignancy such as basal cell carcinoma or squamous cell carcinoma are eligible; however this is not required for enrollment.
- •The suspicious skin lesion(s) is accessible to optical probe measurements. If patient has previous histologically confirmed malignancy of the skin, then the primary tumor site must be accessible to optical probe measurements
- •Patient is able to provide written informed consent
- •Patient is >18 years of age
排除标准
- •< 18 years of age
- •Unable to provide written informed consent
结局指标
主要结局
spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue.
时间窗: 1 day visit
Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis.
次要结局
未报告次要终点