Assessment of Mandibular Bone Invasion With MRI Using SWIFT

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01817140
First received: March 20, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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 3T and 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
Oral Cancer

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
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: NCT01817140

Contacts
Contact: Patricia Fernandes, DDS, MS 612-626-3018 ferna079@umn.edu
Contact: Samir Khariwala, MD 612-625-7495 khari001@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Patricia Fernandes, DDS, MS    612-626-3018    ferna079@umn.edu   
Contact: Samir Khariwala, MD    612-625-7495    khari001@umn.edu   
Principal Investigator: Samir Khariwala, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Samir Khariwala, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01817140     History of Changes
Other Study ID Numbers: NM2012-06-06
Study First Received: March 20, 2013
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014