Overview

This trial is active, not recruiting.

Condition brain tumors
Treatment mri
Phase phase 0
Sponsor University of Michigan
Collaborator National Institutes of Health (NIH)
Start date September 1999
End date December 2017
Trial size 190 participants
Trial identifier NCT00724191, 5P01CA085878-12, CA85878-12, HUM 00051052

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Evaluation of new MRI methods that measure information related to the chemical makeup of the brain in patients undergoing therapy for brain tumors.
mri
New MRI methods which measure information related to water, blood, and chemical makeup in the brain.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Quantitation of Human Brain Tumor Therapy Response by MR
Principal investigator Thomas L. Chenevert, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Michigan.