Assessment of Mandibular Bone Invasion With MRI Using SWIFT

NCT01817140 | Completed DMC

• 1 other identifier: NM2012-06-06
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Keywords

oral cancer; mandibular invasion; SWIFT MRI

Outcome Measures

Primary Outcomes (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".

  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.

  Up to 15 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Samir Khariwala, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)