MRI Imaging of the Human Larynx

This study has been terminated.

(Absence of key personnel to conduct study)

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT00965003

First received: August 21, 2009

Last updated: December 12, 2013

Last verified: December 2013

History of Changes

Purpose

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
Scan 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

Eligibility


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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965003

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Edward J. Damrose MD, FACS	Stanford University

More Information


Responsible Party:	Stanford University
ClinicalTrials.gov 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 Neoplasms Otorhinolaryngologic Neoplasms	Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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