MRI Imaging of the Human Larynx
This study has been terminated.
(Absence of key personnel to conduct study)
Information provided by (Responsible Party):
First received: August 21, 2009
Last updated: December 12, 2013
Last verified: December 2013
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.
Head and Neck Cancers
Procedure: MRI scan
||Observational Model: Cohort
Time Perspective: Prospective
||High Resolution MRI in the Evaluation of Laryngeal Neoplasia
Primary Outcome Measures:
- Tumor stage as determined by histopathology in excised larynges. [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
- Estimate the precision of HRMRI in terms of cartilage invasion. [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
- Tumor stage as determined by HRMRI. [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]
- Estimate the precision of HRMRI in discriminating between edema and tumor in patients with prior radiotherapy or chemotherapy. [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
High resolution MRI to be performed of subject larynx
Procedure: MRI scan
Standard of Care
- Magnetic Resonance Imaging
- nuclear magnetic resonance imaging
- magnetic resonance tomography
0.1 mmol/kg, IV
Other Name: gadolinium-based MRI contrast agent
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Laryngeal cancer patients at Stanford University
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965003
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Edward J. Damrose MD, FACS
No publications provided
History of Changes
|Other Study ID Numbers:
||ENT0019, 96536, SU-05292009-2661
|Study First Received:
||August 21, 2009
||December 12, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Diagnostic Uses of Chemicals