Optical Imaging of Head and Neck Cancer

January 8, 2018 updated by: Sharmila Anandasabapathy, MD

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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, 10017
        • Icahn School of Medicine at Mount Sinai

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

Description

Inclusion Criteria:

  • Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx
  • Must be receiving surgical treatment for their cancer

Exclusion Criteria:

  • Presence of medical or psychiatric condition affecting the ability to give informed consent
  • Known allergy to Proflavin
  • Pregnant or nursing Females

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: High Resolution Microendoscopy (HRME)
High Resolution Microendoscopy 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.
Other Names:
  • HRME
Other: Proflavine hemisulfate
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
Other Names:
  • Proflavine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 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
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Sensitivity
Time Frame: 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
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Specificity
Time Frame: 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
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Positive Predictive Value
Time Frame: 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
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Negative Predictive Value
Time Frame: 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
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Interrater Reliability
Time Frame: 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.
Immediately following image (day of enrollment or up to 2 weeks after enrollment)

Collaborators and Investigators

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

Sponsor

Sharmila Anandasabapathy, MD

Collaborators

William Marsh Rice University

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

December 1, 2011

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (ESTIMATE)

October 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 09-2057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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