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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

October 14, 2011
July 23, 2013
December 2011
September 2013   (final data collection date for primary outcome measure)
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.
Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediatedly 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.
Complete list of historical versions of study NCT01456143 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Optical Imaging of Head and Neck Cancer
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma
  • Neoplasia
  • Head and Neck Cancer
  • 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
Experimental: Squamous Cell Carcinoma
Patients with Head and Neck Squamous Cell Carcinoma undergoing surgical resection
Interventions:
  • Drug: Proflavine
  • Device: High Resolution Microendoscope
  • Device: Identafi 3000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
77
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andrew Sikora, MD, PhD 212-241-5944 andrew.sikora@mssm.edu
United States
 
NCT01456143
GCO 09-2057
No
Sharmila Anandasabapathy, Mount Sinai School of Medicine
Sharmila Anandasabapathy
William Marsh Rice University
Principal Investigator: Andrew Sikora, MD, PhD Mount Sinai School of Medicine
Principal Investigator: Sharmila Anandasabapathy, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP