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NCT00230295 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00230295
Other study ID # ENT0010
Secondary ID ENT0010
Status Completed
Phase N/A
First received September 28, 2005
Last updated July 23, 2010
Start date February 2003
Est. completion date November 2007

Study information
Verified date July 2010
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H&N with primary tumor sites that are accessible to direct contrast injections

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• IMR LAG

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

Sponsors (2)
Lead Sponsor Collaborator
Stanford University McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 unknown No
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