MRI Laryngeal Imaging With a Surface Coil
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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
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Condition or disease | Intervention/treatment | Phase |
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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) |
Primary Purpose: | Diagnostic |
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 |
Arm | Intervention/treatment |
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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.
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Procedure: MRI scan
Standard of Care
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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 |
Responsible Party: | Edward J. Damrose, Associate Professor of Otolaryngology, Stanford University |
ClinicalTrials.gov Identifier: | NCT00965003 History of Changes |
Other Study ID Numbers: |
ENT0019 96536 ( Other Identifier: Stanford University Alternate IRB Approval Number ) SU-05292009-2661 ( Other Identifier: Stanford University ) |
First Posted: | August 25, 2009 Key Record Dates |
Last Update Posted: | October 5, 2017 |
Last Verified: | October 2017 |
Additional relevant MeSH terms:
Head and Neck Neoplasms Laryngeal Neoplasms Neoplasms by Site Neoplasms Otorhinolaryngologic Neoplasms |
Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases |