MRI Laryngeal Imaging With a Surface Coil

Larynx Cancer Clinical Trial

Official title:

High Resolution MRI in the Evaluation of Laryngeal Neoplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00965003
• Other study ID #: ENT0019
• Secondary ID: 96536SU-05292009
• Status: Terminated
• Phase: Early Phase 1
• First received: August 21, 2009
• Last updated: October 3, 2017
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancers
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Larynx Cancer

Intervention

Procedure:
• MRI scan
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor stage as determined by HRMRI.	Radiologic tumor stage	24 to 48 hours
Secondary	Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy.	Comparison of true tumor dimension as predicted by HRMRI versus true tumor size as shown on final histopathology	4 to 6 weeks
Secondary	Tumor stage as determined by histopathology in excised larynges.	Pathological tumor stage	4 to 6 weeks