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

NCT00724191 | Completed

• 3 other identifiers: HUM 000510525P01CA085878-12CA85878-12
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

MRI PROCEDURE

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Univeristy of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas L. Chenevert, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 1999
• Primary Completion: January 15, 2014
• Study Completion: January 15, 2014
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)