High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

University of Texas Southwestern Medical Center1 site in 1 country184 target enrollmentAugust 28, 2009

ConditionsBrain Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Tumor
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 184
Locations: 1
Primary Endpoint: Benefit of 7T MR imaging
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will compare two different size MRI's of a brain tumor.

Detailed Description

The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.

Registry

clinicaltrials.gov

Start Date

August 28, 2009

End Date

April 20, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Texas Southwestern Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age 18 years or older
•Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
•Histological diagnosis of a brain tumor
•Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
•Pre-operative brain MR imaging suggestive of a brain tumor
•Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
•Patient able and willing to provide informed consent
•Karnofsky Performance status \> 70%
•Life expectancy greater than 3 months
•Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control

Exclusion Criteria

•Body weight \>137 Kg (300 lbs)
•Patient unable to provide informed consent
•Karnofsky Performance status \< 70%
•Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
•NYHA class III and IV congestive heart failure
•Psychiatric or addictive disorders that preclude obtaining informed consent
•Unstable angina
•Sexually active patients of childbearing potential not using a reliable contraceptive method
•Pregnant or lactating women
•Women of childbearing potential who refuse a pregnancy test (performed during screening)

Outcomes

Primary Outcomes

Benefit of 7T MR imaging

Time Frame: Baseline and 6 month intervals after baseline

1. To determine the benefit of 7T MR imaging in brain tumor patients with regard to the improvement in resolution, as measured by the area of T2 FLAIR signal abnormality and the ability to detect abnormalities in vascular integrity. The benefit will be determined at a single time point as well as longitudinally for each patient at 6 month intervals.