High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

NCT02035852 | Completed DMC

• 2 other identifiers: STU 062010-1601R01CA154843-01A1
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vascular Integrity

  Every 6 months, up to 12 months.

Study Arms (1)

Adult Gilomas

Other: MRI

Interventions

MRI OTHER

3T MRI vs. 7T MRI

Adult Gilomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Simmons Cancer Center at UTSW

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elizabeth Maher, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: January 14, 2014
• Study Start: August 28, 2009
• Primary Completion: April 19, 2018
• Study Completion: April 20, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-11

Locations

US (1)