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OpenTrials
Completed

NCT Number: NCT02035852

High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI

Other

3T MRI vs. 7T MRI

Primary outcomes

  1. Benefit of 7T MR imaging

    Time frame: Baseline and 6 month intervals after baseline

    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2014
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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