Viewing Study NCT00965003


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Study NCT ID: NCT00965003
Status: TERMINATED
Last Update Posted: 2017-10-05
First Post: 2009-08-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: MRI Laryngeal Imaging With a Surface Coil
Sponsor: Stanford University
Organization:

Study Overview

Official Title: High Resolution MRI in the Evaluation of Laryngeal Neoplasia
Status: TERMINATED
Status Verified Date: 2017-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Absence of key personnel to conduct study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
96536 OTHER Stanford University Alternate IRB Approval Number View
SU-05292009-2661 OTHER Stanford University View