MedTrace Logo

MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

NCT04596930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-09

No results posted yet for this study

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

Interventions

PROCEDURE

Laser ablation thermal therapy

The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2022-02-11
Completion
2022-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596930 on ClinicalTrials.gov