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NCT00568360 Clinical Trial

Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00568360
Other study ID # ENT0014
Secondary ID 79938SU-11062007
Status Terminated
Phase N/A
First received December 4, 2007
Last updated May 16, 2012
Start date February 2004
Est. completion date August 2009

Study information
Verified date May 2012
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for determining the extent of tumor involvement. However, not all areas involved by tumor are apparent visually. Preliminary results indicate that compared with normal tissues, tumors have abnormal levels of capillary oxygenation. The purpose of this study is to determine the ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm blow the tissue surface.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Oximeter

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

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