NCT04596930

MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care. Study design: Prospective randomized pilot study. Randomization stopped (amendment September 2nd, 2021), Study population: 20 patients aged \>= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection. Intervention: Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy alone (n=10).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Laser ablation thermal therapy	The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-02-11
• Completion: 2022-05-31
• First posted: 2020-10-22
• Last updated: 2022-08-09

Locations

1 site across 1 country: Netherlands