Recruiting

Observational Study

Sponsor:

Zenalux Biomedical, Inc.

Code:

NCT02943044

Conditions

Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 24 - 70+

Healthy Volunteers: Not accepted

Interventions

No intervention, this is an observational study

Study Details

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

Study ID

NCT02943044

Start date

Dec, 2016

Status verified date

Mar, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Walter Lee, MD

More Information

Sponsor

Zenalux Biomedical, Inc.

Last update posted

Mar 3, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zenalux Biomedical, Inc. on 2017-03-03.