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Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03181581
Enrollment
5
Registered
2017-06-09
Start date
2017-03-01
Completion date
2018-12-31
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Glioma

Keywords

ultrasonography, ultrasonics, brain, surgery

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.

Interventions

BIOLOGICALacoustic coupling fluid

ultrasound images obtained with both ACF and Ringer's acetate

ultrasound images obtained with Ringer's acetate only

Sponsors

Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy
CollaboratorUNKNOWN
SINTEF Health Research
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
difference in serious adverse event rates (test minus control)72 hoursNon-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

Secondary

MeasureTime frameDescription
image artefacts1 dayduring the operation; Qualitative score of ultrasound image quality (poor-medium-good)
depiction of outline of the anatomy surrounding the resection cavity1 dayduring the operation; Qualitative score of ultrasound image quality (poor-medium-good)
image signal-to-noise ratio1 dayafter the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)

Other

MeasureTime frameDescription
Quality of Life1 monthassessed by EQ5D (generic)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026