NCT02893137

Enhancing Optune Therapy With Targeted Craniectomy

Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to \~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent. The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DEVICE	Optune	For further information see www.optune.com
PROCEDURE	Craniectomy	A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2016-09-08
• Last updated: 2019-11-27

Locations

1 site across 1 country: Denmark