Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology
研究概览
简要总结
To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.
详细描述
Primary objective:
-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.
Secondary objective:
-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
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
- •Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
- •Ability to understand and willingness to sign a written Informed Consent Document (ICD).
排除标准
- •Known allergy to proflavine or acriflavine.
- •Age less than 18 years.
- •Pregnant or nursing females.
- •Adults unable to consent
- •Prisoners and other vulnerable populations
研究组 & 干预措施
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
干预措施: Proflavine hemisulfate (Drug)
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
干预措施: High Resolution Microendoscope (HRME) (Device)
The Active Biopsy Guidance System
This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
干预措施: Optical Mapping Scope (Device)
结局指标
主要结局
To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology
时间窗: Through study completion an average of 1 year.
次要结局
未报告次要终点