- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00602992
Exploring the Role of 3T MRI in Gamma Knife Radiosurgery
June 21, 2016 updated by: University Health Network, Toronto
Exploring the Role of 3T MRI in Gamma Knife Radiosurgery: A Pilot Study
Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target.
MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery.
Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in turn the quality of images.
However, the technology also introduces new limitations, and the role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet been reported.
In this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3T MRI in patients receiving radiosurgery.
The preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials.
Up to fifty patients will be enrolled in this study.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
45
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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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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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
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who have consented to Gamma Knife radiosurgery.
Description
Inclusion Criteria:
- Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study.
Exclusion Criteria:
- Age<18
- Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cynthia Ménard, MD, University Health Network, Toronto
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
August 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 19, 2007
First Submitted That Met QC Criteria
January 26, 2008
First Posted (Estimate)
January 28, 2008
Study Record Updates
Last Update Posted (Estimate)
June 23, 2016
Last Update Submitted That Met QC Criteria
June 21, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0427-CE
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.