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Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation

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ClinicalTrials.gov Identifier: NCT00313027
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Carcinoma, Squamous Cell Head and Neck Cancers Radiation: PET scan Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cervical Nodal Metastasis in Squamous Cell Carcinoma of the Head and Neck - Novel MRI, FDG-PET, and Histopathologic Correlation
Study Start Date : November 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis. [ Time Frame: pre and post surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy.

Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied.

- Pregnancy.


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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): NCT00313027


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. Stanford University

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00313027     History of Changes
Other Study ID Numbers: ENT0011
78639
ENT0011
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site