Clinical trial NCT00965003: MRI Laryngeal Imaging With a Surface Coil
Official title: High Resolution MRI in the Evaluation of Laryngeal Neoplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Laryngeal Neoplasms
Head and Neck Cancers
Larynx Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Tumor stage as determined by HRMRI.
timeFrame: 24 to 48 hours
Secondary outcomes:
measure: Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.
timeFrame: 4 to 6 weeks
measure: Tumor stage as determined by histopathology in excised larynges.
timeFrame: 4 to 6 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Edward J. Damrose MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: