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MRI Imaging of the Human Larynx

This study has been terminated.
(Absence of key personnel to conduct study)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: August 21, 2009
Last updated: December 12, 2013
Last verified: December 2013
To determine if high resolution MRI can detect early invasion of cartilage by laryngeal carcinoma, and to determine if high resolution MRI may be superior to conventional MRI imaging or CT imaging to detect cartilage invasion.

Condition Intervention
Laryngeal Neoplasms Head and Neck Cancers Larynx Cancer Procedure: MRI scan Device: Gadoversetamide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution MRI in the Evaluation of Laryngeal Neoplasia

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tumor stage as determined by histopathology in excised larynges. [ Time Frame: 4 to 6 weeks ]
  • Estimate the precision of HRMRI in terms of cartilage invasion. [ Time Frame: 4 to 6 weeks ]
  • Tumor stage as determined by HRMRI. [ Time Frame: 24 to 48 hours ]
  • Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy. [ Time Frame: 4 to 6 weeks ]

Enrollment: 3
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
High resolution MRI to be performed of subject larynx
Procedure: MRI scan
Standard of Care
Other Names:
  • Magnetic Resonance Imaging
  • nuclear magnetic resonance imaging
  • magnetic resonance tomography
Device: Gadoversetamide
0.1 mmol/kg, IV
Other Name: gadolinium-based MRI contrast agent


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Laryngeal cancer patients at Stanford University

Inclusion Criteria:

  • Patients with benign or malignant neoplasm of the larynx.
  • Patients who have undergone prior surgery, radiation therapy, or chemotherapy for cancer of the laryngopharynx will be eligible to participate.
  • Patients 18 years of age and older at time of evaluation, male and female, all ethnicities.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Pregnancy
  • Claustrophobia.
  • Anatomic parameters which preclude scanning, such as limited range of neck motion, or inability to remain flat for at least 15 minutes.
  • Patients with implanted devices (eg, defibrillator, pacemaker) that are a known contraindication to magnetic resonance imaging.
  • Allergy to gadolinium contrast.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00965003

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Edward J. Damrose MD, FACS Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT00965003     History of Changes
Other Study ID Numbers: ENT0019
96536 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-05292009-2661 ( Other Identifier: Stanford University )
Study First Received: August 21, 2009
Last Updated: December 12, 2013

Additional relevant MeSH terms:
Head and Neck Neoplasms
Laryngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases processed this record on June 23, 2017