Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device
Completed
Conditions studied: Central Nervous System Lesion
In brief
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).
Key facts
- Study ID
- NCT03088579
- Run by
- St. Joseph's Hospital and Medical Center, Phoenix
- People needed
- 120
- Starts
- 2013-04-02
- Expected to finish
- 2020-08-11
- Last updated by the study team
- 2023-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 18 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).
Where it is running
- Barrow Brain and Spine — Phoenix, Arizona, United States
- Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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