MRI Laryngeal Imaging With a Surface Coil
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00965003|
Recruitment Status : Terminated (Absence of key personnel to conduct study)
First Posted : August 25, 2009
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Laryngeal Neoplasms Head and Neck Cancers Larynx Cancer||Procedure: MRI scan||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Resolution MRI in the Evaluation of Laryngeal Neoplasia|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- Tumor stage as determined by HRMRI. [ Time Frame: 24 to 48 hours ]Radiologic tumor stage
- Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy. [ Time Frame: 4 to 6 weeks ]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. [ Time Frame: 4 to 6 weeks ]Pathological tumor stage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965003
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Edward J. Damrose MD, FACS||Stanford University|