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CompletedNCT02035852Updated Jan 2, 2019

High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

An observational study in Brain Tumor, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-02.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
184
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Brain Tumor

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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 184 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients at the Simmons Cancer Center at UTSW

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
184 participants (actual)
Patient registry
No

Groups and cohorts

  • Adult Gilomas

    Other: MRI

Interventions

  • OtherMRI

    3T MRI vs. 7T MRI

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What researchers measure

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.

    Time frame: Baseline and 6 month intervals after baseline

Secondary outcomes

  1. Vascular Integrity

    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.

    Time frame: Every 6 months, up to 12 months.

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Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02035852
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 14, 2014
Start date
Aug 28, 2009
Primary completion
Apr 19, 2018
Completion
Apr 20, 2018
Last update
Jan 2, 2019

Study contacts

Elizabeth Maher, MD
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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