Quantitative Optical Sensor Findings in Head & Neck Squamous Cell Carcinoma

NCT02943044 | Unknown

• 2 other identifiers: Pro000659675R42CA156901-03
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

No intervention, this is an observational study DEVICE

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

Eligibility Criteria

• Age: 24 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zenalux Biomedical, Inc.: lead
• Duke University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Walter Lee, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Walker

CONTACT

919-684-1732; amy.walker1@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)