High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

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

Study Overview

• Status: Completed
• Conditions: Brain Tumor
• Intervention / Treatment: Other: MRI

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.

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at the Simmons Cancer Center at UTSW

Description

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
• Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T * Spanish speaking participants will be enrolled for this study

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult Gilomas	Other: MRI; 3T MRI vs. 7T MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benefit of 7T MR imaging	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.	Baseline and 6 month intervals after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular Integrity	To determine if changes in vascular integrity at 7T can be correlated with tumor progression or transformation to high grade in patients with low grade gliomas.	Every 6 months, up to 12 months.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elizabeth Maher, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2009
• Primary Completion (Actual): April 19, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: STU 062010-160; 1R01CA154843-01A1 (U.S. NIH Grant/Contract)