MRI Laryngeal Imaging With a Surface Coil

NCT ID: NCT00965003

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-01-31

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.

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.

Conditions

Laryngeal Neoplasms; Head and Neck Cancers; Larynx Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI scan

Intervention Type: PROCEDURE

Standard of Care

Interventions

MRI scan

Standard of Care

Intervention Type: PROCEDURE

Other Intervention Names

Magnetic Resonance Imaging; nuclear magnetic resonance imaging; magnetic resonance tomography

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Edward J. Damrose

Associate Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward J. Damrose MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

96536

Identifier Type: OTHER

Identifier Source: secondary_id

SU-05292009-2661

Identifier Type: OTHER

Identifier Source: secondary_id

ENT0019

Identifier Type: -

Identifier Source: org_study_id