Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01321892

Enrollment

Registered

2011-03-24

Start date

2009-06-30

Completion date

2012-05-31

Last updated

2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharynx, Larynx, Oropharynx, Squamous Cell Carcinoma of the Oral Cavity

Keywords

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

Brief summary

The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy and Interrater Reliability of HRME Image Interpretation	baseline	We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)

Countries

United States

Outcome results