We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Assessment of Mandibular Bone Invasion With MRI Using SWIFT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01817140
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2013
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

The primary objective of this study is to improve the diagnostic accuracy and specificity of MRI in detecting the degree of bone involvement and invasion in oral cancer. The presence and degree of bone invasion determines the extent of surgery and has great effect on the morbidity of patients with oral cancer and bone/soft tissue tumors.

MRI scanning in 3 Tesla (3T) and 4Tesla (4T) MR magnet will be performed on up to 10 patients with possible maxillofacial and/or mandibular bone invasion. We will then compare the conventional imaging results of the patients with 3T and 4T MRI results and post operative pathology results.

Condition or disease
Oral Cancer

Detailed Description:

Unfortunately, detecting bone invasion and extension of bone involvement prior to surgery is often difficult with the currently available imaging techniques. MRI with high contrast resolution and the ability to perform multiplanar imaging plays an integral role in the delineation of tumoral involvement of the bone. Although MRI is an excellent tool in the assessment of bone invasion in carcinoma, its overestimation of cortical invasion and tumor extent to the bone marrow have been a diagnostic challenge, leading to false positive results. Like many of the musculoskeletal system tissues, cortical bone produces no signal with conventional MRI techniques, limiting the characterization of image contrast and differentiation of adjacent soft tissues. A novel MRI technique called Sweep Imaging with Fourier Transformation (SWIFT) appears to be a suitable tool to overcome this challenge. The main advantage of SWIFT is to obtain signal from the cortical bone. We believe that the SWIFT technique will overcome the false positive results.

Patients enrolled in this study will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota, Minneapolis, Minnesota for a scheduled MRI. Brief scans will be obtained (less than 1 minute) to localize the area of interest. Longer MRI scans (around 5-15 minutes each) will then be obtained. The total time required for scanning will be about 1 hour.

To determine how well our MR images will predict the presence of mandibular invasion, we will compare our results with clinical, operative, radiological and pathological findings. Thus, patients will be asked to give permission to the investigators to access the relevant medical records.

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Mandibular Bone Invasion With Magnetic Resonance Imaging (MRI) Using Sweep Imaging Fourier Transformation (SWIFT)
Study Start Date : April 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Ability of the newly created coil to detect mandibular bone invation in patients with squamous cell carcinoma adjacent to, or involving, the mandible. Comparison will be made to histopathological sections as the "gold standard". [ Time Frame: Up to 15 months ]
    The goal of this outcome measure is to generate images, the quality of which are similar to histopathologic sections, with SWIFT MRI allowing determination of the presence or absence and degree of mandibular invasion of squamous cell carcinoma.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of oral cancer with clinical or imaging findings suggestive of maxillofacial or mandibular bone invation

Inclusion Criteria:

  • Patients with a diagnosis of oral cancer with clinical or imaging findings suggestive of maxillofacial or mandibular bone invasion.
  • Patients who will be undergoing surgery as treatment for their oral cancer.

Exclusion Criteria:

  • Pregnancy
  • Ferromagnetic implant
  • History of shotgun wounds and shrapnel
  • Obesity (>250 pounds)
  • Cardiac pacemaker
  • MR incompatible medical device
  • Severe claustrophobia
  • Surgeries with potential ferromagnetic implants
  • Metallic ink tattoo in close proximity to area of interest.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817140

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Samir Khariwala, MD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01817140     History of Changes
Other Study ID Numbers: NM2012-06-06
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
oral cancer
mandibular invasion

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases