Quantitative Optical Sensor Findings in Head & Neck Squamous Cell Carcinoma

Characterization of Physiological and Morphological Features of Clinical Head & Neck Squamous Cell Carcinomas (HNSCCs) Using a Quantitative Optical Sensor

The goal of this study is to determine the optical spectroscopy characteristics of tumor in patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of all head and neck cancers. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. These readings will be performed in the operating room during routine endoscopy with biopsy and tumor mapping of patients who have a suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure sensor will be used to compare biopsy sites with their benign counterparts. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with unknown primaries in which numerous directed biopsies are obtained from multiple head and neck sites.

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Carcinoma
• Intervention / Treatment: Device: No intervention, this is an observational study

Detailed Description

PURPOSE OF THE STUDY:

HYPOTHESES:

Noninvasive optical spectroscopic measurements of Head and Neck Squamous Cell Carcinoma (HNSCC) result in unique signatures that can differentiate between dysplasia, normal, other benign conditions as well as response to radiation therapy as assessed by clinical and histopathological methods.

STUDY OBJECTIVES

1. Characterization of physiological and morphological features of clinical HNSCCs using a spectroscopy based quantitative optical sensor
2. Evaluate the built-in pressure sensor of the probe as a means of making more measurements at a more consistent, narrower pressure range.

This device will be used to compare spectroscopy measurements with histopathological diagnoses. Subjects will undergo optical measurements at the time of routine biopsy for a suspected squamous cell carcinoma of the head and/or neck . Diffuse reflectance spectroscopy measurements from each lesion of clinical interest, as well as distant normal tissue. Three to five repeated scans will be obtained at each measured site. The clinical "tumor" site will then be biopsied. Samples will not be collected from normal tissue for biopsy. The results of the spectroscopy measurements are for research purposes only and will not be used to confirm a subject's diagnosis.

The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. The protocol measurements take less than one minute per site. The total amount of extended OR time is expected to be less than 5 minutes. No additional charges to the subject and/or insurance company is expected.

Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Amy Walker; Phone Number: 919-684-1732; Email: AMY.WALKER1@DUKE.EDU
      • Principal Investigator: Walter Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients between the ages of 24 - 89 who are scheduled for routine panendoscopy and biopsy for suspected Head & Neck Squamous Cell Carcinoma.

Description

Inclusion Criteria:

• Patients undergoing panendoscopy and biopsy for suspected squamous cell carcinoma of the head and neck.
• patient is > 24 to <89 years of age
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• < 24 years of age, >89 years of age
• Unable to provide written informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Optical spectroscopic measurements of tumors in patients with HNSCC compared to the histopathologic diagnosis.	During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements

Secondary Outcome Measures

Outcome Measure	Time Frame
Optimal pressure levels of the optical probe	During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements
Added pressure sensing and self-calibration features of the optical probe improves specificity and sensitivity to differentiate HNSCC from their benign counterparts	During the time of routine biopsy, approximately 5 minutes will be used to perform the optical measurements

Collaborators and Investigators

• Sponsor: Zenalux Biomedical, Inc.
• Collaborators: National Cancer Institute (NCI); Duke University
• Investigators: Principal Investigator: Walter Lee, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: Pro00065967; 5R42CA156901-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be de-identified prior to being shared outside of Duke.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No