Optical Imaging of Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Resolution Microendoscopy (HRME)
Proflavine hemisulfate
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HRME with proflavine
Arm Description
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.
Outcomes
Primary Outcome Measures
Accuracy
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Sensitivity
Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
Specificity
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
Positive Predictive Value
PPV = proportion of those with a positive test who have neoplasia compared to pathology results
Negative Predictive Value
NPV = proportion of those with a negative test without neoplasia compared to pathology results
Interrater Reliability
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01456143
First Posted
October 14, 2011
Last Updated
January 8, 2018
Sponsor
Sharmila Anandasabapathy, MD
Collaborators
William Marsh Rice University
1. Study Identification
Unique Protocol Identification Number
NCT01456143
Brief Title
Optical Imaging of Head and Neck Cancer
Official Title
In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
PI left, study to be re-open with new PI, no planned data analysis
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharmila Anandasabapathy, MD
Collaborators
William Marsh Rice University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer
Keywords
Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HRME with proflavine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Resolution Microendoscopy (HRME)
Other Intervention Name(s)
HRME
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Proflavine hemisulfate
Other Intervention Name(s)
Proflavine
Intervention Description
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
Primary Outcome Measure Information:
Title
Accuracy
Description
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Title
Sensitivity
Description
Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Title
Specificity
Description
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Title
Positive Predictive Value
Description
PPV = proportion of those with a positive test who have neoplasia compared to pathology results
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Title
Negative Predictive Value
Description
NPV = proportion of those with a negative test without neoplasia compared to pathology results
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Title
Interrater Reliability
Description
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.
Time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sikora, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharmila Anandasabapathy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Optical Imaging of Head and Neck Cancer
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