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LITT for Ultra-early GBM Recurrence

28 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

12

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Szwajcaria
      • Bern, Szwajcaria, 3010
        • Rekrutacyjny
        • Dep. of Neurosurgery, Bern University Hospital
        • Kontakt:
          • Alexis Terrapon, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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:

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: LITT Group
Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT
Urządzenie: LITT
Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT.
Brak interwencji: Control Group 1 ("No recurrence")
Patients with no recurrence on pre-RT MRI, proceeding directly to RT.
Brak interwencji: Control Group 2 ("No LITT")
Patients with recurrence but ineligible for LITT, proceeding to another resection or to RT without laser therapy.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Rate of patients who successfully complete the planned treatment
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Complications of LITT
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: pre RT-MRI
Proportion of recruited patients who present with progression on pre-RT MRI
pre RT-MRI
Inclusion rate
Ramy czasowe: pre RT-MRI
Rate of recruited patients who agree to receiving LITT
pre RT-MRI
Treatment rate
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Insel Gruppe AG, University Hospital Bern

Śledczy

  • Główny śledczy: Philippe Schucht, MD, Inselspital Bern, Department of Neurosurgery

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 lutego 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2027

Ukończenie studiów (Szacowany)

31 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

24 listopada 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 maja 2026

Pierwszy wysłany (Rzeczywisty)

1 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-01709

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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