Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
18 Years
N/A
Both
Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Larynx, Hypopharynx
Trial Information
Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Outcome Measure:
Accuracy and Interrater Reliability of HRME Image Interpretation
Outcome Description:
We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
Outcome Time Frame:
baseline
Safety Issue:
No
Principal Investigator
Andrew Sikora, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mount Sinai School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
GCO # 09-0945
NCT ID:
NCT01321892
Start Date:
June 2009
Completion Date:
May 2012
Related Keywords:
- Squamous Cell Carcinoma of the Oral Cavity
- Oropharynx
- Larynx
- Hypopharynx
- HRME
- High-resolution microendoscope
- Optical imaging technology
- Non-invasive fluorescence and reflectance imaging
- Upper aerodigestive tract
- Cancer surgery
- Squamous cell carcinoma
- Oral cavity
- Oropharynx
- Larynx
- Hypopharynx
- Squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx
- Carcinoma
- Carcinoma, Squamous Cell
- Laryngeal Diseases
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
