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临床试验/NCT03181581
NCT03181581终止2 期

Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue: a Phase II Technical and Safety Study

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
发起方
入组人数
5
试验地点
1
主要终点
difference in serious adverse event rates (test minus control)

研究概览

简要总结

Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.

Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult.

This research group has developed an acoustic coupling fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • A diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).
  • In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis.
  • Karnofsky performance status >=70

排除标准

  • Not able to consent (e.g. severe cognitive impairment)
  • Intended biopsy only (meaning: cases not suitable for resection)
  • Hypersensitivity to egg protein
  • Hypersensitivity to soya or peanut protein
  • Hypersensitivity to glycerol
  • Pregnancy of breast-feeding
  • Intention to become pregnant during the time of the study

研究组 & 干预措施

Low-high grade gliomas stage 2 control

Active Comparator

If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma

干预措施: Ringer's acetate (Biological)

High grade gliomas stage 1 ACF

Experimental

In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group.

干预措施: acoustic coupling fluid (Biological)

Low-high grade gliomas stage 2 ACF

Experimental

If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma

干预措施: acoustic coupling fluid (Biological)

High grade gliomas stage 1 control

Active Comparator

In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group.

干预措施: Ringer's acetate (Biological)

结局指标

主要结局

difference in serious adverse event rates (test minus control)

时间窗: 6 months

Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin

次要结局

  • image artefacts(1 day)
  • image signal-to-noise ratio(1 day)
  • depiction of outline of the anatomy surrounding the resection cavity(1 day)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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