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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Dana Foundation
Information provided by (Responsible Party):
Thomas L.Chenevert, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00724191
First received: July 24, 2008
Last updated: June 24, 2014
Last verified: June 2014
  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 Phase
Brain Tumors
Procedure: MRI
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitation of Human Brain Tumor Therapy Response by MR

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To determine if new MRI methods that measure information related to the brain will give an earlier determination as to how well patients with brain tumors are responding to treatment. [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: September 1999
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 to 5 additional contrast enhanced research MRI scans.
  • 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, for example, aneurysm clips, pacemakers, or artificial joints or limbs. It is extremely important that you tell us about any and all surgeries you have had so that we might now if there is a chance that any metal would be inside you. Also, if your job or any other experience might have left metal fragments in your body, please let us know, as the MRI's strong magnetic field could disturb 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

Locations
United States, Michigan
Univeristy of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
The Dana Foundation
Investigators
Principal Investigator: Thomas L. Chenevert, Ph.D University of Michigan
  More Information

No publications provided

Responsible Party: Thomas L.Chenevert, PhD, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00724191     History of Changes
Other Study ID Numbers: HUM 00051052, NIH, NCI, CA 85878
Study First Received: July 24, 2008
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

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 September 18, 2014