MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

Not Applicable

Completed

• Conditions: Glioblastoma
• Interventions: Procedure: Laser ablation thermal therapy

• Registration Number: NCT04596930
• Lead Sponsor: Radboud University Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2021-01-22
• Status Verified: 2021-09
• Primary Completion: 2022-02-11
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LITT arm	Laser ablation thermal therapy	Patients will be randomized to receive biopsy and LITT (n=10)

Primary Outcome Measures

Name	Time	Method
Inclusion rate of patients meeting the inclusion criteria	12 months	To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number drop out (informed consent)	30 days	To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number of patients with completed follow-up at 3 months	3 months	To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
30-days mortality	30 days	To assess safety of LITT at our center in patients with irresectable glioblastoma
Number of patients with complications	3 months	To assess safety of LITT at our center in patients with irresectable glioblastoma
Time from inclusion to procedure	3 months	To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time from LITT to adjuvant therapy	3 months	To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Ablation of 90 percent of the target lesion in at least 70 percent of patients	3 months	To assess feasibility of LITT at our center in patients with irresectable glioblastoma

Secondary Outcome Measures

Name	Time	Method
Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)	3 months	To assess preliminary data on quality of life
European Organisation for Research and Treatment of Cancer - BN20 brain module	3 months	To assess preliminary data on quality of life
Tumor volume evolution	3 months	To assess tumour volume evolution on MRI at 3 months post-operatively
Overall survival and progression free survival	12 months	To assess preliminary data on survival

Trial Locations

Locations (1)

Radboud UMC; 🇳🇱 Nijmegen, Netherlands