Expired Study
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Stanford, California 94305


Purpose:

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.


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.


Study is Available At:


Original ID:

ENT0014


NCT ID:

NCT00568360


Secondary ID:

79938


Study Acronym:


Brief Title:

Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer


Official Title:

Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:

Research cancelled; equipment broke


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter Maxim PhD
Principal Investigator
Stanford University

Study Dates

Start Date:February 2004
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 16, 2012
First Received Date:December 4, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Device
Name:Oximeter

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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