Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas

NCT07384884 | Not Yet Recruiting

• 1 other identifier: 359416
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GBM; Brain Tumours

Keywords

brain tumour

Outcome Measures

Primary Outcomes (1)

• Assessment of Neurocognitive Function

  To assess post-operative neurocognitive function using the Montreal Cognitive Assessment

  12 months

Secondary Outcomes (2)

• Progression-free survival in years

  12 months

• Assessing Quality of Life

  12 months

Study Arms (1)

Surgical resection followed by LITT

OTHER

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

Interventions

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines PROCEDURE

All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.

Also known as: laser interstitial thermal therapy

Surgical resection followed by LITT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic: collaborator
• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

GB (1)