Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

This study has been completed.
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01321892
First received: March 21, 2011
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.


Condition
Squamous Cell Carcinoma of the Oral Cavity
Oropharynx
Larynx
Hypopharynx

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

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

Primary Outcome Measures:
  • Accuracy and Interrater Reliability of HRME Image Interpretation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)


Biospecimen Retention:   Samples Without DNA

Retained specimens are punch biopsy specimens from the primary tumor resection.


Enrollment: 64
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.

Detailed Description:

The overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. The results of this laboratory study will be used to further refine and develop this technology for in vivo application.

Primary Aim:

(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.

Secondary Aims:

  1. To compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue.
  2. To compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with new head and neck cancer, who reside in the tri-state area.

Criteria

Inclusion Criteria:

  • Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx.
  • Must be receiving surgical treatment for their cancer.

Exclusion Criteria:

• Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.

  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: NCT01321892

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
William Marsh Rice University
Investigators
Principal Investigator: Andrew Sikora, MD, PhD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01321892     History of Changes
Other Study ID Numbers: GCO # 09-0945
Study First Received: March 21, 2011
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
HRME
High-resolution microendoscope
Optical imaging technology
Non-invasive fluorescence and reflectance imaging
Upper aerodigestive tract
Cancer surgery
Squamous cell carcinoma
Oral cavity
Oropharynx
Larynx
Hypopharynx
Squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on October 21, 2014