Clinical trial NCT01817140: Assessment of Mandibular Bone Invasion With MRI Using SWIFT
Official title: Assessment of Mandibular Bone Invasion With Magnetic Resonance Imaging (MRI) Using Sweep Imaging Fourier Transformation (SWIFT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Keywords: oral cancer
mandibular invasion
SWIFT MRI
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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 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.

Primary outcomes:
measure: 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".
timeFrame: Up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Samir Khariwala, MD
role: PRINCIPAL_INVESTIGATOR
References: