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LITT for Ultra-early GBM Recurrence

28. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

12

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Schweiz
      • Bern, Schweiz, 3010
        • Rekrutierung
        • Dep. of Neurosurgery, Bern University Hospital
        • Kontakt:
          • Alexis Terrapon, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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:

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of patients who successfully complete the planned treatment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Complications of LITT
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: pre RT-MRI
Proportion of recruited patients who present with progression on pre-RT MRI
pre RT-MRI
Inclusion rate
Zeitfenster: pre RT-MRI
Rate of recruited patients who agree to receiving LITT
pre RT-MRI
Treatment rate
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Insel Gruppe AG, University Hospital Bern

Ermittler

  • Hauptermittler: Philippe Schucht, MD, Inselspital Bern, Department of Neurosurgery

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Februar 2026

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

24. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-01709

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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