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MRI Laryngeal Imaging With a Surface Coil

Primary Purpose

Laryngeal Neoplasms, Head and Neck Cancers, Larynx Cancer

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI scan
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Laryngeal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI scan with surface coil

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor stage as determined by HRMRI.
Radiologic tumor stage

Secondary Outcome Measures

Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.
Comparison of true tumor dimension as predicted by HRMRI versus true tumor size as shown on final histopathology
Tumor stage as determined by histopathology in excised larynges.
Pathological tumor stage

Full Information

First Posted
August 21, 2009
Last Updated
October 3, 2017
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00965003
Brief Title
MRI Laryngeal Imaging With a Surface Coil
Official Title
High Resolution MRI in the Evaluation of Laryngeal Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Absence of key personnel to conduct study
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Neoplasms, Head and Neck Cancers, Larynx Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI scan with surface coil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Other Intervention Name(s)
Magnetic Resonance Imaging, nuclear magnetic resonance imaging, magnetic resonance tomography
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Tumor stage as determined by HRMRI.
Description
Radiologic tumor stage
Time Frame
24 to 48 hours
Secondary Outcome Measure Information:
Title
Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.
Description
Comparison of true tumor dimension as predicted by HRMRI versus true tumor size as shown on final histopathology
Time Frame
4 to 6 weeks
Title
Tumor stage as determined by histopathology in excised larynges.
Description
Pathological tumor stage
Time Frame
4 to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward J. Damrose MD, FACS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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MRI Laryngeal Imaging With a Surface Coil

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