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NCT00313027 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Cervical Nodal Metastasis in Squamous Cell Carcinoma of the Head and Neck - Novel MRI, FDG-PET, and Histopathologic Correlation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00313027
Other study ID # ENT0011
Secondary ID 78639ENT0011
Status Completed
Phase N/A
First received March 27, 2006
Last updated July 5, 2012
Start date November 2002
Est. completion date March 2005

Study information
Verified date July 2012
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Radiation:
• PET scan

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis. pre and post surgery No
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