High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
Conditions
Brain Tumor
Conditions: official terms
Brain Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: MRI
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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

- 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)
Location
UT Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Start Date
August 2009
Completion Date
November 2015
Sponsors
University of Texas Southwestern Medical Center
Source
University of Texas Southwestern Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page