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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02005614 on ClinicalTrials.gov