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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00313027
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2002
• Actual Primary Completion Date: Mar 1, 2005
• Actual Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis. [pre and post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00313027
• Other Study ID Numbers: ENT0011; 78639; ENT0011
• First Posted: Apr 11, 2006
• Last Update Posted: Jul 9, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 9, 2012