Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer

NCT ID: NCT00568360

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oximeter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Maxim PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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79938

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11062007-817

Identifier Type: OTHER

Identifier Source: secondary_id

ENT0014

Identifier Type: -

Identifier Source: org_study_id

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