- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538264
Blood Flow MRI for Monitoring Brain Tumors (Glioma)
April 25, 2024 updated by: David Alsop, Beth Israel Deaconess Medical Center
Blood Flow MRI for Monitoring of Glioma Angiogenesis
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Our goals are:
- 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.
- 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.
- 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.
- 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.
Study Type
Observational
Enrollment (Estimated)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
Inclusion Criteria:
- diagnosed with or are suspected of having a glioma
Exclusion Criteria:
contraindications to MRI which may include the following
- Pacemaker
- MRI incompatible metal implant
- Recently implanted vascular clip
- History of claustrophobia
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David C Alsop, PhD, Beth Israel Deaconess Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
February 23, 2012
First Posted (Estimated)
February 24, 2012
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006P000116
- R01CA115745-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.