Optical Imaging of Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Sharmila Anandasabapathy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01456143
First received: October 14, 2011
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Squamous Cell Carcinoma
Neoplasia
Head and Neck Cancer
Drug: Proflavine
Device: High Resolution Microendoscope
Device: Identafi 3000

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.


Secondary Outcome Measures:
  • Image Correlation with standard of care histopathology [ Time Frame: Following surgical resection - (day of enrollment or up to 2 weeks after enrollment.) ] [ Designated as safety issue: No ]
    participants are imaged after their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.


Estimated Enrollment: 77
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Squamous Cell Carcinoma
Patients with Head and Neck Squamous Cell Carcinoma undergoing surgical resection
Drug: Proflavine
swabbing the area to be imaged prior to tumor resection with .01% proflavine hemisulfate, a fluorescent dye. Will be placed on site for approximately 30-45 seconds.
Other Name: proflavine hemisulfate
Device: High Resolution Microendoscope
Use of this imaging system after application with proflavin
Other Name: HRME
Device: Identafi 3000
use of this system to obtain optical images

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456143

Contacts
Contact: Andrew Sikora, MD, PhD 212-241-5944 andrew.sikora@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10017
Contact: Nadia Camille       nadia.camille@mountsinai.org   
Principal Investigator: Andrew Sikora, MD, PhD         
Principal Investigator: Brett A Miles, DDS MD FACS         
Sponsors and Collaborators
Sharmila Anandasabapathy
William Marsh Rice University
Investigators
Principal Investigator: Andrew Sikora, MD, PhD Mount Sinai School of Medicine
Principal Investigator: Sharmila Anandasabapathy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Sharmila Anandasabapathy, Principle Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01456143     History of Changes
Other Study ID Numbers: GCO 09-2057
Study First Received: October 14, 2011
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Squamous Cell Carcinoma
Neoplasia
Optical imaging
Head and Neck Cancer
Oropharynx
Larynx
Oral Cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014