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

NCT03088579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-04-12

No results posted yet for this study

Summary

The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT) loader (design patent pending). The reusable device will be made of surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers (HVL) to provide significant staff and user shielding as well as allowing it to be sterilized. It is utilized intraoperatively but off of the operative field and has no direct patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2 inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical Institute (BNI) operating rooms (OR).

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.

Sponsors & Collaborators

  • Arizona Commerce Commission, Phoenix AZ

    collaborator UNKNOWN

  • GT Medical Technologies, Inc.

    collaborator INDUSTRY

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • David G Brachman, MD · Barrow Neurological Institute

  • Peter Nakaji, MD · Barrow Neurological Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-02
Primary Completion
2018-02-28
Completion
2020-08-11

Countries

  • United States

Study Locations

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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 NCT03088579 on ClinicalTrials.gov