LITT for Ultra-early GBM Recurrence

NCT07616986 · tracked via the Priya Life Science Switzerland tracker

Sponsor

Insel Gruppe AG, University Hospital Bern

Phase

Not applicable

Started

2026-02-06

Last updated

2026-06-01

Condition(s) studied

Glioblastoma (GBM)Glioblastoma - Category

Investigational drug(s) / intervention(s)

LITT

LITT: Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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:

Primary outcome measure(s)

Rate of patients who successfully complete the planned treatment — 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).

Trial sites (1)

Facility	City	Region	Status
Dep. of Neurosurgery, Bern University Hospital	Bern	Switzerland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07616986 on ClinicalTrials.gov ↗ ← All trials in Switzerland