In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
详细描述
The purpose of this study is to determine if optical imaging modalities used at the time of surgical resection for head and neck squamous cell carcinoma can help delineate normal from cancerous mucosa. The High resolution microendoscope, developed by our collaborators at Rice university, can allow for real time visualization of tissue nuclei. The overall aim of this study is to determine if this device can be used to enhance the accuracy of intraoperative margin detection during tumor resection for head and neck cancer.
At the time of tumor resection for head and neck squamous cell carcinoma, a wide field imaging device will be used to identify suspicious areas. The High resolution device will then image representative areas from the tumor, the tumor margin, and normal mucosa. A topical dye, proflavin, will be placed on the tissue to enhance the visualization of nuclei prior to imaging with the HRME device. Following imaging, biopsies of the imaged areas will be taken and submitted for pathology diagnosis. The images of the biopsies will then be compared and the device will be evaluated for accuracy of margin detection at the time of tumor resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx
- •Must be receiving surgical treatment for their cancer
排除标准
- •Presence of medical or psychiatric condition affecting the ability to give informed consent
- •Known allergy to Proflavin
- •Pregnant or nursing Females
研究组 & 干预措施
HRME with proflavine
High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
干预措施: High Resolution Microendoscopy (HRME) (Device)
HRME with proflavine
High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
干预措施: Proflavine hemisulfate (Other)
结局指标
主要结局
Specificity
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
Positive Predictive Value
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
PPV = proportion of those with a positive test who have neoplasia compared to pathology results
Negative Predictive Value
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
NPV = proportion of those with a negative test without neoplasia compared to pathology results
Accuracy
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Interrater Reliability
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.
Sensitivity
时间窗: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
次要结局
未报告次要终点
研究者
Sharmila Anandasabapathy, MD
Principal Investigator
Anandasabapathy, Sharmila, M.D.