Clinical trial NCT03181581: Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Neoplasms
Glioma
Keywords: ultrasonography
ultrasonics
brain
surgery
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy
name: SINTEF Health Research
First posted: 2017-06-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: difference in serious adverse event rates (test minus control)
timeFrame: 72 hours
measure: difference in serious adverse event rates (test minus control)
timeFrame: 30 days
measure: difference in serious adverse event rates (test minus control)
timeFrame: 6 months
Secondary outcomes:
measure: image artefacts
timeFrame: 1 day
measure: image artefacts
timeFrame: 1 day
measure: depiction of outline of the anatomy surrounding the resection cavity
timeFrame: 1 day
measure: depiction of outline of the anatomy surrounding the resection cavity
timeFrame: 1 day
measure: image signal-to-noise ratio
timeFrame: 1 day
Other outcomes:
measure: Quality of Life
timeFrame: 1 month
measure: Quality of Life
timeFrame: 1 month
measure: Quality of Life
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
Locations:
city: Trondheim
country: Norway
facility: Department of Neurosurgery, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Petter Aadahl, phd md
role: STUDY_DIRECTOR
References: