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Blood Flow MRI for Monitoring Brain Tumors (Glioma)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01538264
First received: February 20, 2012
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner.

Condition
Brain Tumors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Blood Flow MRI for Monitoring of Glioma Angiogenesis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Estimated Enrollment: 125
Study Start Date: June 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Our goals are:

  1. To compare the blood flow measured with this technique with measures of tumor blood vessel density in pieces of the tumor surgically removed as a normal part of clinical treatment. This will confirm a relationship between the imaging measurements and the microscopic characteristics of tumors.
  2. To compare the blood flow in tumors before therapy with the concentration of choline, an indicator of cell proliferation. This choline concentration can be measured with another MRI technique. This information will demonstrate the relationship between cell proliferation and blood supply and will also determine whether the choline measurement adds additional information that is clinically necessary.
  3. To determine the reproducibility of blood flow measurements in tumors. This is necessary to better understand the sensitivity of the technique to changes in flow caused by a treatment or changes in tumor vascularity.
  4. To monitor changes in blood flow after initial treatment. Since sometimes tumors can reappear, the repeated measures will help determine how useful this new imaging technique is at detecting such recurring tumors.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects will be brain tumor patients recruited through the Brain Tumor Center at the Beth Israel Deaconess Medical Center.
Criteria

Inclusion Criteria:

  • diagnosed with or are suspected of having a glioma

Exclusion Criteria:

  • contraindications to MRI which may include the following

    1. Pacemaker
    2. MRI incompatible metal implant
    3. Recently implanted vascular clip
    4. History of claustrophobia
    5. Metal fragment within the eye

Subjects who have received nonstandard therapy may be excluded if the therapy might alter tumor blood flow or other imaging characteristic.

  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: NCT01538264

Contacts
Contact: Teresa Russell, BS trussell@bidmc.harvard.edu
Contact: Bridget Giarusso, BS bgiaruss@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Teresa Russell, BS       trussell@bidmc.harvard.edu   
Contact: Bridget Giarusso, BS       bgiaruss@bidmc.harvard.edu   
Principal Investigator: David C Alsop, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: David C Alsop, PhD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01538264     History of Changes
Other Study ID Numbers: 2006-P-000116  R01CA115745-05 
Study First Received: February 20, 2012
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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 26, 2016