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High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035852
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
The study will compare two different size MRI's of a brain tumor.

Condition or disease Intervention/treatment
Brain Tumor Other: MRI

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.
Study Design
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Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
Actual Study Start Date : August 28, 2009
Actual Primary Completion Date : April 19, 2018
Actual Study Completion Date : April 20, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Adult Gilomas Other: MRI
3T MRI vs. 7T MRI


Outcome Measures
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Primary Outcome Measures :
  1. Benefit of 7T MR imaging [ Time Frame: 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 :
  1. Vascular Integrity [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the Simmons Cancer Center at UTSW
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035852


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elizabeth Maher, MD UT Southwestern Medical Center
More Information
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02035852    
Other Study ID Numbers: STU 062010-160
1R01CA154843-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases