NCT00602992

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

September 19, 2007

Last Update Submit

June 21, 2016

Conditions

Brain Metastases

Keywords

3T MRIGamma Knife Radiosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have consented to Gamma Knife radiosurgery.

You may qualify if:

  • Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study.

You may not qualify if:

  • Age\<18
  • Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Cynthia Menard, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2007

First Posted

January 28, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

CA(1)