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OpenTrials
Completed

NCT Number: NCT00724191

Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)

The purpose of this study is to determine if new MRI methods that measure various information and chemical makeup in the brain, will give early information regarding response to treatment in patients with brain tumors.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

The purpose of this study is to see if new MRI methods which measure information related to water, blood flow, and chemical makeup in the brain, can give early information of how well treatment is working in patients with brain tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over the age of 18 who have been diagnosed with a brain tumor of the central nervous system and a treatment plan has been discussed.
  • Must be willing/able to undergo 3-5 MRI scans with IV contrast.
  • You can take part in this study if you are NOT afraid of small, enclosed places.

Exclusion criteria

  • A patient who is claustrophobic.
  • Females who are pregnant or lactating.
  • Patients who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prosthesis or or implanted neurological stimulator.
  • Any patient who has a history of allergic reactions to MR contrast agent (Omniscan, Magnevist, MultiHance)
  • Patients who require general anesthesia to complete MRI exam or patients who have had a negative reaction to MRI sedation. (Chloral Hydrate, Pentobarbital or Versed)
  • You should NOT have any metals, or implanted devices in your body (such as aneurysm clips, pacemakers, or artificial joints or limbs.). You will need to tell us about your medical history including any surgeries you have had.

Also, if your job or any other experience might have left metal fragments in your body, please let us know, as the MRI has a strong magnetic field could move a metal fragment in your body or interfere with an implanted device, such as a pacemaker, causing you harm.

Treatment and study plan

MRI

Procedure

New MRI methods which measure information related to water, blood, and chemical makeup in the brain.

Primary outcomes

  1. MRI metrics for brain tumor response

    Time frame: approximately 1 year

    New treatment response MRI metrics derived from change in water diffusion and perfusion from pre-treatment to mid-treatment will be compared to traditional response metrics measured 4 weeks after completion of standard of care chemoradiation for their prediction of patient outcomes and overall survival. The new response metrics are not only measured earlier, but are also quantitative measures for the fraction of tumor exhibiting significant change in diffusion and perfusion assessed on a voxel-by-voxel basis, as well as the volume of dense tumor assessed by analysis of diffusion/perfusion histograms measured over the whole tumor.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Quantitation of Human Brain Tumor Therapy Response by MR

Important dates

Study start
1999
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2008
Registry last updated
May 11, 2020

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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