Brain TumoursSLITT-GBMNCT07384884
Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines in people with Brain Tumours and GBM, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumours, GBM
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2026to 1 Jul 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- bGBM measuring >2.5 cm in both hemispheres.
- Tumour progression between surgical debulking and LITT treatment
- Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College NHS Foundation Trust
London, SE5 9RS
Keyoumars Ashkan, 02032999000, k.ashkan@nhs.net
About this study
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.
Read more
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
- Brain Tumours, GBM
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Keywords
- brain tumour
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection followed by LITT | Other | Combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual. Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Neurocognitive Function
To assess post-operative neurocognitive function using the Montreal Cognitive Assessment
Measured: 12 months
Secondary outcomes (2)
Progression-free survival in years
To evaluate progression-free survival
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start27 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumoursStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384884
- Sponsor's protocol ID
- 359416
- Acronym
- SLITT-GBM
- Status last verified
- May 2026
- First submitted
- 11 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas
- ClinicalTrials.gov ID
- NCT07384884
- Acronym / sponsor ID
- SLITT-GBM / 359416
- Conditions
- Brain Tumours, GBM
- Keywords
- brain tumour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 guidelinesCombined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- bGBM measuring >2.5 cm in both hemispheres.
- Tumour progression between surgical debulking and LITT treatment
- Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesAlso: laser interstitial thermal therapyAll patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual. | Procedure or surgery | Surgical resection followed by LITT |
Primary outcome
Assessment of Neurocognitive Function
Time frame: 12 months
To assess post-operative neurocognitive function using the Montreal Cognitive Assessment
2 secondary outcomes
Progression-free survival in years
Time frame: 12 months
Assessing Quality of Life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines in people with Brain Tumours and GBM, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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 3 Sep 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Neurocognitive Function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.