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

NCT03088579 | Completed

• 1 other identifier: 13RT022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

radiation shielding

Outcome Measures

Primary Outcomes (2)

• User's Experience

  Analyze users' (radiation oncologists and neurosurgeons) experience with the loader methodology by utilizing a standardized questionnaire recording 1) time added to case, 2) the size and size range of implants utilized, 3) conformality to operative bed, and 4) ease of use. Both perceptual (subjective) and numerical (objective) data will be obtained.

  Immediately post-operatively

• Shielding

  Evaluate shielding (radiation protection ability) of shielded loader through mRm measurements while seeds are in loader prior to implantation: surface of loader (mRm/hour), at 1 meter (mRm/hour), and at 3 meter (mRm/hour).

  Immediately post-operatively

Secondary Outcomes (7)

• Post-Implant Dosimetric Analysis

  Post-operative Day 1

• Seed Migration

  Post-operative Day 1

• Economic Impact

  Post-Operative Day 1, at follow-up per routine care (up to 5 years)

• Progression Free Survival (PFS)

  Pre-Operative and at follow-up per routine care (up to 5 year)

• Overall Survival (OS)

  Pre-Operative and at follow-up per routine care (up to 5 year)

Interventions

GammaTile seed loader DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults of either gender having a central nervous system lesion (high grade primary brain tumor and electing intra-operative brachytherapy. Participants will be patients of Barrow Brain and Spine neurosurgery group located in Phoenix AZ.

You may qualify if:

• Planned for resection of aggressive primary or metastatic brain tumor and appropriate for adjuvant radiotherapy.
• Zubrod Performance Score of 0-2.
• years of age or older.
• Pre-operative stereotactic CT or MRI.
• Life expectancy \>26 weeks.
• History and physical for all patients and detailed neurological exams.
• Signed study-specific informed consent form prior to study entry.

You may not qualify if:

• Negative biopsy if presumed diagnosis on imaging.
• External beam therapy is allowed if the implant is being used instead of a boost or cone down treatment.
• Life expectancy \< 26 weeks.
• Inability to undergo post-operative CT for implant assessment, or postoperative follow-up imaging.
• Major medical or psychiatric illness, which, in the investigator's opinion, would prevent completion of treatment and/or interfere with follow-up.
• Inability or refusal to provide informed consent.
• Prior radiation therapy in excess of 100Gy to site of implant.
• Patients in which there is no cranium in place (for example, bone flap removed for infection).

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Arizona Commerce Commission, Phoenix AZ: collaborator
• GT Medical Technologies, Inc.: collaborator

Study Sites (2)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

Related Publications (1)

• Pinnaduwage DS, Srivastava SP, Yan X, Jani S, Brachman DG, Sorensen SP. Dosimetric Impacts of Source Migration, Radioisotope Type, and Decay with Permanent Implantable Collagen Tile Brachytherapy for Brain Tumors. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221106852. doi: 10.1177/15330338221106852.

  PMID: 35712977 DERIVED

Study Officials

• David G Brachman, MD

  Barrow Neurological Institute

  STUDY CHAIR

• Peter Nakaji, MD

  Barrow Neurological Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 23, 2017
• Study Start: April 2, 2013
• Primary Completion: February 28, 2018
• Study Completion: August 11, 2020
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)