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NCT Number: NCT07384884

Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location contact

Keyoumars Ashkan

CONTACT

02032999000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: laser interstitial thermal therapy

Primary outcomes

  1. Assessment of Neurocognitive Function

    Time frame: 12 months

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

Secondary outcomes

  1. Progression-free survival in years

    Time frame: 12 months

    To evaluate progression-free survival

  2. Assessing Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • Medtronic

Registry information

Acronym: SLITT-GBM

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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