MRI Laryngeal Imaging With a Surface Coil | NCT00965003

Studies
MRI Laryngeal Imaging With a Surface Coil

NCT00965003

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Oct 5, 2017Actual

Enrollment

3Actual

Phase

Early Phase 1

Conditions

Laryngeal Neoplasms
Head and Neck Cancers
Larynx Cancer

Interventions

MRI scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
96536	Other Identifier	Stanford University Alternate IRB Approval Number
SU-05292009-2661	Other Identifier	Stanford University

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Absence of key personnel to conduct study

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Aug 21, 2009

First Submission Date that Met QC Criteria

Aug 21, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2017

Last Update Posted Date

Oct 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edward J. Damrose, Associate Professor of Otolaryngology, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MRI scan	Procedure	Standard of Care	MRI scan with surface coil	Magnetic Resonance Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor stage as determined by HRMRI.	Radiologic tumor stage	24 to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
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	4 to 6 weeks
Tumor stage as determined by histopathology in excised larynges.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward J. Damrose MD, FACS	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D007822	Laryngeal Neoplasms
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007818	Laryngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy
D000097873	Postmortem Imaging

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D001344	Autopsy

Browse Leaves

Not provided

Browse Branches

Not provided