MRI Laryngeal Imaging With a Surface Coil

Sponsor
Stanford University (Other)
Overall Status
Terminated
CT.gov ID
NCT00965003
Collaborator
(none)
3
1
1
6
0.5

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
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 :
Jul 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

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

    Primary Outcome Measures

    1. Tumor stage as determined by HRMRI. [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. [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. [4 to 6 weeks]

      Pathological tumor stage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward J. Damrose, Associate Professor of Otolaryngology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00965003
    Other Study ID Numbers:
    • ENT0019
    • 96536
    • SU-05292009-2661
    First Posted:
    Aug 25, 2009
    Last Update Posted:
    Oct 5, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2017