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MRI Laryngeal Imaging With a Surface Coil

High Resolution MRI in the Evaluation of Laryngeal Neoplasia

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00965003
Enrollment
3
Registered
2009-08-25
Start date
2009-07-31
Completion date
2010-01-31
Last updated
2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancers, Laryngeal Neoplasms, Larynx Cancer

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.

Interventions

PROCEDUREMRI scan

Standard of Care

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Tumor stage as determined by HRMRI.24 to 48 hoursRadiologic tumor stage

Secondary

MeasureTime frameDescription
Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.4 to 6 weeksComparison 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.4 to 6 weeksPathological tumor stage

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026