Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
This study is currently recruiting participants.
Verified August 2011 by University of Michigan
Sponsor:
University of Michigan
Collaborators:
The Dana Foundation
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00724191
First received: July 24, 2008
Last updated: August 29, 2011
Last verified: August 2011
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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. [ Designated as safety issue: No ]
| Estimated Enrollment: | 164 |
| Study Start Date: | September 1999 |
| 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
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
The Dana Foundation
Investigators
| Principal Investigator: | Thomas L. Chenevert, Ph.D | University of Michigan |
More Information
No publications provided
| Responsible Party: | Thomas L. Chenevert Ph.D., University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00724191 History of Changes |
| Other Study ID Numbers: | 1999-0509, NIH, NCI, CA 85878 |
| Study First Received: | July 24, 2008 |
| Last Updated: | August 29, 2011 |
| 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 May 21, 2013