MRI Laryngeal Imaging With a Surface Coil

NCT00965003 | Terminated Early Phase 1 DMC

• 3 other identifiers: ENT001996536SU-05292009-2661
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Neoplasms; Head and Neck Cancers; Larynx Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor stage as determined by HRMRI.

  Radiologic tumor stage

  24 to 48 hours

Secondary Outcomes (2)

• Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.

  4 to 6 weeks

• Tumor stage as determined by histopathology in excised larynges.

  4 to 6 weeks

Study Arms (1)

MRI scan with surface coil

EXPERIMENTAL

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

Interventions

MRI scan PROCEDURE

Standard of Care

Also known as: Magnetic Resonance Imaging, nuclear magnetic resonance imaging, magnetic resonance tomography

MRI scan with surface coil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms; Head and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Postmortem Imaging

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging

Study Officials

• Edward J. Damrose MD, FACS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 25, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

US (1)