Back to resultsCervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
Primary Purpose
Head and Neck Cancer, Carcinoma, Squamous Cell, Head and Neck Cancers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00313027
Brief Title
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
Official Title
Cervical Nodal Metastasis in Squamous Cell Carcinoma of the Head and Neck - Novel MRI, FDG-PET, and Histopathologic Correlation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Carcinoma, Squamous Cell, Head and Neck Cancers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
PET scan
Primary Outcome Measure Information:
Title
To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis.
Time Frame
pre and post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Billy W. Loo Jr. M.D. Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
We'll reach out to this number within 24 hrs