跳至主要内容
临床试验/NCT07384884
NCT07384884招募中不适用

Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas

King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12
试验地点
2
主要终点
Assessment of Neurocognitive Function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Surgical resection followed by LITT

Other

Combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.

干预措施: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure)

结局指标

主要结局

Assessment of Neurocognitive Function

时间窗: 12 months

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

次要结局

  • Progression-free survival in years(12 months)
  • Assessing Quality of Life(12 months)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验