- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02365844
Multispectral Imaging to Characterize Patterns of Vascular Supply Within Lymphoepithelial Mucosa in Oropharyngeal Cancer
February 27, 2019 updated by: Stanford University
Multispectral Imaging to Characterize Patterns of Vascular Supply Within the Lymphoepithelial Mucosa of Patients With Known or Suspected Oropharyngeal Carcinoma (OPC)
The purpose of this study is to characterize the blood supply at the base of the tongue and within the tonsil region.
We hypothesize that high-resolution Narrow Band Imaging (NBI) will improve the diagnosis of oropharyngeal carcinoma (OPC).
The goal is to provide the better assessment of tumor and thus providing better preoperative expectations to patients with OPC or tumor extent prior to radiation therapy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 95305
- Stanford University, School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Stanford Cancer Center patients with oropharyngeal carcinoma
Description
Inclusion Criteria:
- age 18 years or older
- Written informed consent
- Patients with oropharyngeal carcinoma
Exclusion Criteria:
- Tumors of the oral cavity or nasopharynx
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of differential vascularity between normal and clinically apparent tumor with in the specified sites of oropharynx, using standard white-light endoscopy and narrow-band imaging
Time Frame: 30 minutes
|
endoscopy of the oropharynx using white-light and narrow-Band imaging
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris Holsinger, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
August 27, 2018
Study Completion (Actual)
August 27, 2018
Study Registration Dates
First Submitted
February 11, 2015
First Submitted That Met QC Criteria
February 11, 2015
First Posted (Estimate)
February 19, 2015
Study Record Updates
Last Update Posted (Actual)
March 1, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENT0044
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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