Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
Ключови думи
Резюме
Описание
The overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. The results of this laboratory study will be used to further refine and develop this technology for in vivo application.
Primary Aim:
(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.
Secondary Aims:
1. To compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue.
2. To compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.
Дати
| Последна проверка: | 05/31/2012 |
| Първо изпратено: | 03/20/2011 |
| Очаквано записване подадено: | 03/21/2011 |
| Първо публикувано: | 03/23/2011 |
| Изпратена последна актуализация: | 06/19/2012 |
| Последна актуализация публикувана: | 06/20/2012 |
| Действителна начална дата на проучването: | 05/31/2009 |
| Приблизителна дата на първично завършване: | 04/30/2012 |
| Очаквана дата на завършване на проучването: | 04/30/2012 |
Състояние или заболяване
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Squamous cell carcinoma Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx. - Must be receiving surgical treatment for their cancer. Exclusion Criteria: • Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent. |
Резултат
Първични изходни мерки
1. Accuracy and Interrater Reliability of HRME Image Interpretation [baseline]
