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MRI Imaging of the Human Larynx

This study has been terminated.
(Absence of key personnel to conduct study)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00965003
First received: August 21, 2009
Last updated: December 12, 2013
Last verified: December 2013
History of Changes
  Purpose
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.

Condition Intervention
Laryngeal Neoplasms
Head and Neck Cancers
Larynx Cancer
 Procedure: MRI scan
Device: Gadoversetamide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution MRI in the Evaluation of Laryngeal Neoplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

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 ]
Enrollment: 3
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Scan
High resolution MRI to be performed of subject larynx
 Procedure: MRI scan
Standard of Care
Other Names:
  • Magnetic Resonance Imaging
  • nuclear magnetic resonance imaging
  • magnetic resonance tomography
Device: Gadoversetamide
0.1 mmol/kg, IV
Other Name: gadolinium-based MRI contrast agent

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Laryngeal cancer patients at Stanford University
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.
  Contacts and Locations
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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Edward J. Damrose MD, FACS Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00965003     History of Changes
Other Study ID Numbers: ENT0019  96536  SU-05292009-2661 
Study First Received: August 21, 2009
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016