Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas (SLITT-GBM)

Butterfly glioblastomas (bGBM), defined as tumours crossing the midline to involve hemispheres bilaterally, have a dismal prognosis with a median survival of 3.3-6 months and only 9% of patients with bGBM survive 2-years. These figures put bGBM in the worst end of the spectrum of GBM prognosis, significantly inferior to the survival figures quoted in the literature with standard of care - 14.6 months - particularly when 5-aminolevulinic acid is used as surgical adjuvant - 17.47 months.

Despite the poor outcome of this disease, there is preliminary evidence suggesting that active oncology treatment can impact the survival of patients with this condition.With particular regards to surgical resection versus biopsy, there is a suggestion that resection improves overall survival at 6 months with no clear difference at 12 and 18 months of follow up.

Laser-induced thermal therapy (LITT) is a minimally invasive laser ablation technique used in a range of brain tumours, including glioblastomas, with similar overall survival to the ones reported for open surgery in patients with lesions not amenable to open resection. The minimally invasive nature of this technique, significantly reducing the collateral damage to the surrounding brain structures, suggests Its potential in the treatment of this bGBM [14] with significant implications as a deficit-sparing technique, particularly if associated with preoperative and intraoperative monitoring and mapping techniques.

The SLITT-GBM study will combine unilateral open surgery for maximal tumour resection with contralateral LITT to the smaller component/residual.

Study Overview

• Status: Not yet recruiting
• Conditions: GBM; Brain Tumours
• Intervention / Treatment: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College NHS Foundation Trust
    • Contact: Keyoumars Ashkan; Phone Number: 02032999000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Presumptive diagnosis of bGBM as per preoperative MRI and MDT assessment
2. Presumed residual / smaller component of the bGBM has to be < 2.5cm
3. Performance Status 0-1
4. Able to consent for the study

Exclusion Criteria:

1. bGBM measuring >2.5 cm in both hemispheres.
2. Tumour progression between surgical debulking and LITT treatment
3. Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgical resection followed by LITT; Combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.	Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines; All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.; Other Names: laser interstitial thermal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Neurocognitive Function	To assess post-operative neurocognitive function using the Montreal Cognitive Assessment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival in years	To evaluate progression-free survival	12 months
Assessing Quality of Life	To assess quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assessment. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, and a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: brain tumour
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Surgical Procedures, Operative
• Other Study ID Numbers: 359416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No