Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas

NCT07384884 — Not applicable, Recruiting, 12 participants, King's College Hospital NHS Trust

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Registry	NCT07384884, acronym SLITT-GBM
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	12 (Estimated)
Sponsor	King's College Hospital NHS Trust (Other); collaborators: Medtronic
Conditions	Brain Tumours, GBM
Interventions	surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure)
Dates	start 2026-04-27, primary completion 2026-12-31 (estimated), completion 2027-07-01 (estimated), first posted 2026-02-03, last updated 2026-09-03
Locations	1 site in United Kingdom

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Surgical resection followed by LITT	Other	Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines	Combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure), also known as laser interstitial thermal therapy: All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.

+Outcome measures

Primary outcomes

Assessment of Neurocognitive Function [12 months]: To assess post-operative neurocognitive function using the Montreal Cognitive Assessment

Secondary outcomes

Progression-free survival in years [12 months]: To evaluate progression-free survival
Assessing Quality of Life [12 months]: 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

+Locations (1)

Facility	City	Country	Status
King's College NHS Foundation Trust	London	United Kingdom	Recruiting