High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

The University of Texas System (UT)

Status: Completed

Conditions: Brain Tumor

Treatments: Other: MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02035852

STU 062010-160

1R01CA154843-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

184 participants in 1 patient group

Adult Gilomas

Treatment:

Other: MRI