Back to resultsIndirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
Primary Purpose
Head and Neck Cancer, Head and Neck Cancers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMR LAG
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H&N with primary tumor sites that are accessible to direct contrast injections
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
Secondary Outcome Measures
Full Information
NCT ID
NCT00230295
First Posted
September 28, 2005
Last Updated
July 23, 2010
Sponsor
Stanford University
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00230295
Brief Title
Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
Official Title
Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
4. Oversight
5. Study Description
Brief Summary
To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
IMR LAG
Primary Outcome Measure Information:
Title
To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H&N with primary tumor sites that are accessible to direct contrast injections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quynh-Thu Le
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
Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
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