This trial is active, not recruiting.

Condition brain tumor
Treatment mri
Sponsor University of Texas Southwestern Medical Center
Collaborator National Cancer Institute (NCI)
Start date August 2009
End date January 2018
Trial size 184 participants
Trial identifier NCT02035852, 1R01CA154843-01A1, STU 062010-160


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
3T MRI vs. 7T MRI

Primary Outcomes

Benefit of 7T MR imaging
time frame: Baseline and 6 month intervals after baseline

Secondary Outcomes

Vascular Integrity
time frame: Every 6 months, up to 12 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
Principal investigator Elizabeth Maher, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.