Quantitative Optical Sensor Findings in Head & Neck Squamous Cell Carcinoma

NCT ID: NCT02943044

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention, this is an observational study

Non interventional, non-invasive measurements of tissue samples suspected of squamous cell carcinoma using an optical probe.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Zenalux Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Walker

Role: CONTACT

amy.walker1@duke.edu

919-684-1732

Facility Contacts

Amy Walker

Role: primary

amy.walker1@duke.edu

919-684-1732

Other Identifiers

5R42CA156901-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00065967

Identifier Type: -

Identifier Source: org_study_id