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

Brain Tumors Clinical Trial

Official title:

Quantitation of Human Brain Tumor Therapy Response by MR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724191
• Other study ID #: HUM 00051052
• Secondary ID: 5P01CA085878-12C
• Status: Completed
• Start date: September 1999
• Est. completion date: January 15, 2014

Study information

• Verified date: May 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 15, 2014
• Est. primary completion date: January 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Univeristy of Michigan Health System	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI metrics for brain tumor response	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.	approximately 1 year