LITT for Ultra-early GBM Recurrence

May 28, 2026 updated by: Insel Gruppe AG, University Hospital Bern

Laser Interstitial Thermal Therapy for Ultra-Early, Pre-Radiotherapy Glioblastoma Recurrence

Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT/CT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy.

LITT offers a minimally invasive alternative that may:

  • Treat recurrence without delaying RT/CT
  • Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

GBM is frequent and still has a poor prognosis. Standard therapy consists of complete resection of enhancing tumor (CRET) followed by RT and CT. At the institution, patients planned for RT undergo a pre-radiotherapy planning MRI. As recently published, >40% of patients exhibit contrast-enhancing tumor recurrence in the short interval between early postoperative MRI and pre-RT MRI, despite CRET in the initial surgery. This ultra-early recurrence is strongly associated with shorter OS: in the cohort, median overall survival (OS) was 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Hence, pre-radiation GBM recurrence is a frequent event with detrimental consequences for patients.

Reoperation in this setting is rarely performed as it delays adjuvant treatment, which worsen prognosis further. LITT is an established, minimally invasive treatment form for brain lesions such as glioblastoma recurrences and metastases. LITT may offer a solution to this dilemma as its minimal invasiveness enables to ablate the recurrent tumor without delaying treatment. As an additional benefit, LITT may work as a potent sensitizer to subsequent RT and CT.

A key challenge in the implementation of LITT in this setting is the tight scheduling window (maximum 1 week) between pre-radiotherapy planning MRI and start of radiotherapy. In order not to delay adjuvant treatment, LITT should optimally be performed within this time window. To be feasible, both planning and execution of LITT, including coordination of intraoperative MRI and engineering support, must occur within this short timeframe. This feasibility study aims to prospectively investigate whether LITT can be integrated into the existing care pathway without postponing of adjuvant treatment. This may lay the groundwork for future clinical trials.

Objective:

The aim is to test feasibility of integrating scheduling, planning and execution of LITT into the standard treatment course of patients with CRET-resected glioblastoma scheduled to receive concomitant radio-chemotherapy. The primary objective of this feasibility study is to evaluate the feasibility of performing LITT for ultra-early recurrence following GBM resection without delaying adjuvant radio-chemotherapy.

Secondary objectives are collected to estimate the effect size of pre-RT LITT on median overall survival compared to patients with ultra-early recurrence who do not receive LITT, and to historic controls; the purpose of these endpoints is to guide power calculations of a subsequent phase II trial.

Methods:

This is a prospective, single-arm, monocentric feasibility study conducted at the University Department of Neurosurgery, Inselspital, Bern. The study is exploratory in nature and aims to generate foundational data for a larger, multi-centric phase II trial. At the University Hospital of Bern, all patients are presented to the tumor board after surgery for brain tumors. All patients with histologically confirmed glioblastoma and without residual contrast enhancement (CRET) meeting the inclusion criteria for study participation will be asked for consent and, where applicable, included in the trial. All patients showing ultra-early recurrence on planning MRI and meeting the inclusion criteria for LITT will be considered to undergo LITT before the beginning of radiotherapy. Patients without recurrence ("no recurrence" group) and patients with recurrence who do not undergo LITT ("recurrence/no LITT" group) will serve as internal control groups.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Dep. of Neurosurgery, Bern University Hospital
        • Contact:
          • Alexis Terrapon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed glioblastoma, IDH-wildtype, regardless of MGMT status
  • ≥18 years of age
  • CRET
  • Karnofsky Performance Status (KPS) ≥70
  • No contra-indication for radio-chemotherapy
  • Scheduled for adjuvant radio-chemotherapy at University Hospital of Bern
  • Able to provide informed consent
  • No contra-indication for LITT
  • No pregnancy or active breast-feeding
  • No known coagulopathy independent of medication
  • No dissemination or multifocal disease
  • Patients lacking capacity to consent or considered vulnerable (e.g., minors, those under legal protection) are not included.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LITT Group
Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT
Device: LITT
Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT.
No Intervention: Control Group 1 ("No recurrence")
Patients with no recurrence on pre-RT MRI, proceeding directly to RT.
No Intervention: Control Group 2 ("No LITT")
Patients with recurrence but ineligible for LITT, proceeding to another resection or to RT without laser therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients who successfully complete the planned treatment
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Proportion of CRET patients who successfully complete the planned treatment protocol without protocol violation, until the end of radiation therapy. A protocol violation is defined as any of the following: a delay of more than 7 days in the scheduled pre-RT MRI, LITT procedure, or RT initiation, or an interruption of RT due to a LITT-related event. The study teams aims to describe logistical and organizational difficulties (coordination of intraoperative MRI-availability, engineering support).
from enrollment to the end of radiotherapy, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of LITT
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Any deviation from the normal postoperative course, including any new appearance of blood during LITT MRI, any seeding along the trajectory of the probe, any pathological wound condition such as dehiscence or infection
from enrollment to the end of radiotherapy, an average of 8 weeks
Delay of Radiotherapy
Time Frame: assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection
Measurement of the time-lag between planning MRI and beginning of radiation, and comparsion to pre-planned radiation start
assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection
Use of steroids
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Use of steroids: Binary (yes/no) and, if applicable, dose and duration
from enrollment to the end of radiotherapy, an average of 8 weeks
Evolution of radiation necrosis
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Any increase of the size of the contrast enhancing lesion
from enrollment to the end of radiotherapy, an average of 8 weeks
Evolution of target lesion
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Any increase of the size of the contrast enhancing lesion
from enrollment to the end of radiotherapy, an average of 8 weeks
Evolution of pseudoprogression
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Any increase of the size of the contrast enhancing lesion
from enrollment to the end of radiotherapy, an average of 8 weeks
Time to local recurrence
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Time from detection of relapse to detection of local glioblastoma recurrence (lesion within/at the borders of the surgical cavity or associated FLAIR/T2 hyperintensity)
from enrollment to the end of radiotherapy, an average of 8 weeks
Time to distant recurrence
Time Frame: from enrollment to the end of radiotherapy, an average of 8 weeks
Time from detection of relapse to detection of distant glioblastoma recurrence (outside the borders of the surgical cavity or associated FLAIR/T2 hyperintensity)
from enrollment to the end of radiotherapy, an average of 8 weeks
Median overall survival
Time Frame: from enrollment to date of death, assessed up to the end of the study period (end of ratiotherapy for the last included patient)
Median overall survival measured from first surgery to death
from enrollment to date of death, assessed up to the end of the study period (end of ratiotherapy for the last included patient)
Site of recurrence
Time Frame: assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection
Spatial position of the recurrence (local adjacent, distant)
assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection
Recruitment rate
Time Frame: at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant
Proportion of CRET patients who agree to participate
at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant
Progression rate
Time Frame: pre RT-MRI
Proportion of recruited patients who present with progression on pre-RT MRI
pre RT-MRI
Inclusion rate
Time Frame: pre RT-MRI
Rate of recruited patients who agree to receiving LITT
pre RT-MRI
Treatment rate
Time Frame: at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant
Rate of recruited patients who receive LITT
at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Philippe Schucht, MD, Inselspital Bern, Department of Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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