Assessment of Mandibular Bone Invasion With MRI Using SWIFT

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Assessment of Mandibular Bone Invasion With Magnetic Resonance Imaging (MRI) Using Sweep Imaging Fourier Transformation (SWIFT)

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Mar 22, 2013
Registry last updated: May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed