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Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00568360
Recruitment Status : Terminated (Research cancelled; equipment broke)
First Posted : December 6, 2007
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief 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.

Condition or disease Intervention/treatment
Head and Neck Cancer Device: Oximeter

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer
Study Start Date : February 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568360


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Peter Maxim PhD Stanford University

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00568360     History of Changes
Other Study ID Numbers: ENT0014
79938 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-11062007-817 ( Other Identifier: Stanford University )
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms