Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.
研究概览
简要总结
This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.
II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.
SECONDARY OBJECTIVES:
I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.
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 oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head & neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible
- •Ability to understand and the willingness to sign a written informed consent document (ICD)
排除标准
- •Known allergy to proflavine or acriflavine
- •Pregnant or nursing females
- •The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
研究组 & 干预措施
Diagnostic (widefield multispectral imaging and HRME)
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
干预措施: High-Resolution Microendoscopy (Procedure)
Diagnostic (widefield multispectral imaging and HRME)
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
干预措施: Proflavine (Drug)
Diagnostic (widefield multispectral imaging and HRME)
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
干预措施: Multispectral Imaging (Procedure)
结局指标
主要结局
Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.
时间窗: 1 day
Images obtained will be compared against the histology slides of tissue taken from the same region.
Classification of tissue
时间窗: 1 day
Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer
次要结局
- Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions(1 day)
- Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye(1 day)