High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

Completed

• Conditions: Brain Tumor
• Interventions: Other: MRI

• Registration Number: NCT02035852
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-08-28
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2018-04-19
• Study Completion: 2018-04-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-12-28
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Gilomas	MRI	-

Primary Outcome Measures

Name	Time	Method
Benefit of 7T MR imaging	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.

Secondary Outcome Measures

Name	Time	Method
Vascular Integrity	Every 6 months, up to 12 months.	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.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States