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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00313027
First received: March 27, 2006
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Head and Neck Cancer
Carcinoma, Squamous Cell
Head and Neck Cancers
 Radiation: PET scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis. [ Time Frame: pre and post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00313027     History of Changes
Other Study ID Numbers: ENT0011, 78639, ENT0011
Study First Received: March 27, 2006
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013