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Trial record 39 of 11745 for:    Oral Cancer

Assessment of Mandibular Bone Invasion With MRI Using SWIFT

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ClinicalTrials.gov Identifier: NCT01817140
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.


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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Other
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
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Group/Cohort
Patient MRI
Adult patients with possible maxillofacial and/or mandibular bone invasion with oral cancer or osteoradionecrosis who are scheduled for surgery. All eligible and consented participants will have MRI scans obtained using 3T and 4T magnets prior to their surgery.
Normal MRI
Healthy adult volunteers recruited to test the comfort of the coil apparatus and to determine configurations which lead to satisfactory image acquisition.



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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.

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


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Samir Khariwala, MD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:

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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: May 7, 2019
Last Verified: May 2019

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

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