MRI Laryngeal Imaging With a Surface Coil

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Laryngeal Neoplasms; Head and Neck Cancers; Larynx Cancer	Procedure: MRI scan	Early Phase 1

Detailed Description:

The purpose of this study is to use a new MRI imaging coil developed for enhancing structures made of cartilage to determine if the device can produce improved images of the human larynx. In addition, if enhanced images can be obtained, a further purpose will be to determine if, in patients with laryngeal cancer, whether or not early invasion of cartilage can be detected. Patients with laryngeal cancer will be asked to undergone an MRI scan using this new image-enhancing coil to see if cartilage invasion can be detected. Patients will be followed during and after treatment to determine their ultimate response to treatment. No additional MRI scans for the purposes of this protocol will be performed other than the initial pretreatment scan.

We hope to determine if this new MRI imaging device can detect early cancer invasion of the laryngeal cartilages in patients with laryngeal cancer. Since this modality has never been attempted before on the human larynx, we are simply looking for the presence or absence of cartilage destruction. Both conventional CT and conventional MRI are poor at recongnizing this finding. High resolution MRI may allow the detection of this finding or it may not - detection of this finding is the endpoint.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	High Resolution MRI in the Evaluation of Laryngeal Neoplasia
Study Start Date :	July 2009
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	January 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: MRI scan with surface coil; Patients with known laryngeal cancer, with suspected cartilage involvement by conventional computed tomography scanning, who undergo high resolution magnetic resonance imaging enhanced with a surface coil placed over the larynx.	Procedure: MRI scan; Standard of Care; Other Names: Magnetic Resonance Imaging; nuclear magnetic resonance imaging; magnetic resonance tomography

Outcome Measures

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Primary Outcome Measures :

1. Tumor stage as determined by HRMRI. [ Time Frame: 24 to 48 hours ]
   Radiologic tumor stage

Secondary Outcome Measures :

1. Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy. [ Time Frame: 4 to 6 weeks ]
   Comparison of true tumor dimension as predicted by HRMRI versus true tumor size as shown on final histopathology
2. Tumor stage as determined by histopathology in excised larynges. [ Time Frame: 4 to 6 weeks ]
   Pathological tumor stage

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Edward J. Damrose, Associate Professor of Otolaryngology, 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 )
First Posted:	August 25, 2009
Last Update Posted:	October 5, 2017
Last Verified:	October 2017

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