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In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

18 Years
Open (Enrolling)
Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer

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Trial Information

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

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.

Inclusion Criteria:

- Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx,

- Must be receiving surgical treatment for their cancer

Exclusion Criteria:

- Presence of medical or psychiatric condition affecting the ability to give informed

- Known allergy to Proflavin

- Pregnant or nursing Females

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Accuracy and Interrate Reliability of HRME Image Interpretation

Outcome Description:

participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.

Outcome Time Frame:

Immediately following image (day of enrollment or up to 2 weeks after enrollment)

Safety Issue:


Principal Investigator

Andrew Sikora, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

September 2013

Related Keywords:

  • Squamous Cell Carcinoma
  • Neoplasia
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Neoplasia
  • Optical imaging
  • Head and Neck Cancer
  • Oropharynx
  • Larynx
  • Oral Cavity
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Mount Sinai School of MedicineNew York, New York  10029