Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

June 20, 2012 updated by: Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029-6574
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with new head and neck cancer, who reside in the tri-state area.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

William Marsh Rice University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO # 09-0945

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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