A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection
NCT02005614 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2019-07-01
Summary
The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.
Conditions
Interventions
- PROCEDURE
-
Gamma Knife Radiosurgery
Treatment will be administered on an outpatient basis. No other treatment, investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's brain metastases. Gamma knife radiosurgery is a one day out-patient procedure. Time from initiation of treatment (premedication and placement of a stereotactic frame) until end of treatment (completion of radiation delivery and removal of stereotactic frame) ranges from 3 to 16 hours.
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
James B Yu, MD · Yale University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2018-02-28
- Completion
- 2018-08-31
Countries
- United States
Study Locations
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