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Glioblastoma (GBM)NCT07616986

LITT for Ultra-early GBM Recurrence

A study testing LITT in people with Glioblastoma (GBM) and Glioblastoma - Category, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma (GBM), Glioblastoma - Category
What is being tested?
LITT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSwitzerland
Study dates
6 Feb 2026to 31 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe Schucht, MD contact

+41 31 632 00 14

philippe.schucht@insel.ch

Alexis P. R. Terrapon, MD contact

+41 31 66 4 02 39

alexis.terrapon@insel.ch

Switzerland1 site, 1 recruiting
  • Dep. of Neurosurgery, Bern University Hospital

    Bern, 3010

    Alexis Terrapon, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.
Read the 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.

Being tested
LITT
Keywords
LITT, Laser Interstitial Thermal Therapy, ultra-early recurrence, GMB, GMB recurrence, GMB ultra-early recurrence
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LITTDevice

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

Study groups in NCT07616986
Study groupRoleWhat they receive
LITT GroupExperimentalPatients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT
Receives: Device: LITT
Control Group 1 ("No recurrence")No interventionPatients with no recurrence on pre-RT MRI, proceeding directly to RT.
Control Group 2 ("No LITT")No interventionPatients with recurrence but ineligible for LITT, proceeding to another resection or to RT without laser therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients who successfully complete the planned treatment

    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).

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

Secondary outcomes (14)
  1. Complications of LITT

    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

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  2. Delay of Radiotherapy

    Measurement of the time-lag between planning MRI and beginning of radiation, and comparsion to pre-planned radiation start

    Measured: assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection

  3. Use of steroids

    Use of steroids: Binary (yes/no) and, if applicable, dose and duration

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  4. Evolution of radiation necrosis

    Any increase of the size of the contrast enhancing lesion

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  5. Evolution of target lesion

    Any increase of the size of the contrast enhancing lesion

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  6. Evolution of pseudoprogression

    Any increase of the size of the contrast enhancing lesion

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  7. Time to local recurrence

    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)

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  8. Time to distant recurrence

    Time from detection of relapse to detection of distant glioblastoma recurrence (outside the borders of the surgical cavity or associated FLAIR/T2 hyperintensity)

    Measured: from enrollment to the end of radiotherapy, an average of 8 weeks

  9. Median overall survival

    Median overall survival measured from first surgery to death

    Measured: from enrollment to date of death, assessed up to the end of the study period (end of ratiotherapy for the last included patient)

  10. Site of recurrence

    Spatial position of the recurrence (local adjacent, distant)

    Measured: assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection

  11. Recruitment rate

    Proportion of CRET patients who agree to participate

    Measured: at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant

  12. Progression rate

    Proportion of recruited patients who present with progression on pre-RT MRI

    Measured: pre RT-MRI

  13. Inclusion rate

    Rate of recruited patients who agree to receiving LITT

    Measured: pre RT-MRI

  14. Treatment rate

    Rate of recruited patients who receive LITT

    Measured: at study completion (date of end of radiotherapy for the last included patient, approximately 2 years after enrollment of the first participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start6 Feb 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616986
Sponsor's protocol ID
2025-01709
Other IDs
2025
Status last verified
May 2026
First submitted
24 Nov 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Terrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121.

    PubMed 33887774
  • Schaff LR, Mellinghoff IK. Glioblastoma and Other Primary Brain Malignancies in Adults: A Review. JAMA. 2023 Feb 21;329(7):574-587. doi: 10.1001/jama.2023.0023.

    PubMed 36809318
  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PubMed 15758009
  • Waqar M, Roncaroli F, Lehrer EJ, Palmer JD, Villanueva-Meyer J, Braunstein S, Hall E, Aznar M, De Witt Hamer PC, D'Urso PI, Trifiletti D, Quinones-Hinojosa A, Wesseling P, Borst GR. Rapid early progression (REP) of glioblastoma is an independent negative prognostic factor: Results from a systematic review and meta-analysis. Neurooncol Adv. 2022 Jun 4;4(1):vdac075. doi: 10.1093/noajnl/vdac075. eCollection 2022 Jan-Dec.

    PubMed 35769410
  • McGrath K, Frain M, Hey G, Rahman M. Complications following laser interstitial thermal therapy: a review. Neurochirurgie. 2025 Jan;71(1):101604. doi: 10.1016/j.neuchi.2024.101604. Epub 2024 Oct 23.

    PubMed 39413572
  • Rangwala HS, Shafique MA, Mustafa MS, Kumar R, Devi J, Rangwala BS, Ali SMS, Raja A, Iqbal J, Ali M, Haseeb A. Evaluating efficacy and safety of laser interstitial thermal therapy in patients with newly diagnosed and recurrent glioblastoma: a systematic review and meta-analysis. Neurosurg Rev. 2024 Nov 12;47(1):846. doi: 10.1007/s10143-024-03077-6.

    PubMed 39528836
  • Yu JS, Meade SM, Zhao R, Wei W, Dashora H, Prayson R, Grabowski MM, Stevens G, Lobbous M, Murphy ES, Suh JH, Chao ST, Barnett GH, Peereboom D, Ahluwalia MS, Mohammadi AM. Expedited chemoradiation after laser interstitial thermal therapy (LITT) is feasible and safe in patients with newly diagnosed glioblastoma. Neurooncol Adv. 2025 Feb 14;7(1):vdaf038. doi: 10.1093/noajnl/vdaf038. eCollection 2025 Jan-Dec.

    PubMed 40276375
  • Hani L, Hakim A, Gehrig L, Staruch M, Goldberg J, Russli S, Soll N, Raabe A, Ermis E, Schucht P. Identification and relevance of ultra-early progression after resection of glioblastoma. J Neurosurg. 2025 Jul 25;143(5):1315-1324. doi: 10.3171/2025.3.JNS242212. Print 2025 Nov 1.

    PubMed 40712164

Questions about this trial

What is this clinical trial studying?

A study testing LITT in people with Glioblastoma (GBM) and Glioblastoma - Category, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe Schucht, MD (+41 31 632 00 14, philippe.schucht@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients who successfully complete the planned treatment (time frame: from enrollment to the end of radiotherapy, an average of 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07616986, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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