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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Thomas L Chenevert, PhD, University of Michigan
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas L Chenevert, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00724191
First received: July 24, 2008
Last updated: June 22, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Brain Tumors Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitation of Human Brain Tumor Therapy Response by MR

Resource links provided by NLM:


Further study details as provided by Thomas L Chenevert, PhD, University of Michigan:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 190
Study Start Date: September 1999
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Evaluation of new MRI methods that measure information related to the chemical makeup of the brain in patients undergoing therapy for brain tumors.
Procedure: MRI
New MRI methods which measure information related to water, blood, and chemical makeup in the brain.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over of 18 who have been diagnosed with a brain tumor of the central nervous system. Patients must have a treatment plan for their brain tumor from their physician.
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724191

Contacts
Contact: Thomas L. Chenevert, Ph.D 734-936-8866 tlchenev@umich.edu

Locations
United States, Michigan
Univeristy of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Thomas L Chenevert, Ph.D.    734-936-8866    tlchenev@umich.edu   
Principal Investigator: Thomas L. Chenevert, Ph.D.         
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas L. Chenevert, Ph.D University of Michigan
  More Information

Responsible Party: Thomas L Chenevert, PhD, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00724191     History of Changes
Other Study ID Numbers: HUM 00051052
5P01CA085878-12 ( U.S. NIH Grant/Contract )
CA85878-12 ( Other Grant/Funding Number: National Cancer Institute )
Study First Received: July 24, 2008
Last Updated: June 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2017