Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00230295
First received: September 28, 2005
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention
Head and Neck Cancer
Head and Neck Cancers
Procedure: IMR LAG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast

Resource links provided by NLM:


Further study details as provided by Stanford University:

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 [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (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:Patients with newly diagnosed squamous cell carcinomas of the H&N with primary tumor sites that are accessible to direct contrast injections

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230295

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Quynh-Thu Le Stanford University
  More Information

No publications provided

Responsible Party: Quynh-Thu Le, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00230295     History of Changes
Other Study ID Numbers: ENT0010, ENT0010
Study First Received: September 28, 2005
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014