Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device

CompletedOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

April 2, 2013

Primary Completion Date

February 28, 2018

Study Completion Date

August 11, 2020

Conditions
Central Nervous System Lesion
Interventions
DEVICE

GammaTile seed loader

Patients are chosen based on symptomatic tumor/radiographic finding of a surgically accessible mass. Surgery will be done in usual fashion. A cavity will be left where the tumor was. Size of operative bed will be measured using a surgical dissector and standard operating room ruler. A sheet of surgical fabric may be used to estimate size of cavity. If pathology is positive the study treatment will continue. If not, patient will not be on trial. If patient is eligible, radiation oncologist will form custom implants using a seed(s) of Cesium-131, with other biocompatible materials used to achieve maximum dosimetric conformality. Surgeon will place constructs into cavity until the operative bed is fully addressed. Implant is not expected to migrate. Surgicel, bioglue or similar material may be used to secure seeds. Wound will be closed in standard fashion. The last 10 patients will be asked to participate in an effort to gauge costs related to radiation portion of treatment.

Trial Locations (2)

85013

Barrow Brain and Spine, Phoenix

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix

Sponsors
All Listed Sponsors
collaborator

Arizona Commerce Commission, Phoenix AZ

UNKNOWN

collaborator

GT Medical Technologies, Inc.

INDUSTRY

lead

St. Joseph's Hospital and Medical Center, Phoenix

OTHER