An interventional study of SonoClear ACF in Brain Tumour, High Grade Glioma and Low-grade Glioma, sponsored by SonoClear AS. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by SonoClear AS · Not applicable, Interventional, and Other
The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale.
This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.
Ultrasound images will be obtained at different timepoints during the operation. First timepoint being after craniotomy (no fluids involved). Second timepoint being when some tumour is left in the bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and third timepoint being when the surgeon deems resection of the tumour to be completed. At the second and third timepoint ultrasound acquisition will be performed twice at each timepoint. Once with routinely used saline / Ringer's solution and once with SonoClear ACF.
There are two performance related primary endpoints, based on core lab assessments:
This SIR is designed to explore whether SonoClear ACF, having shown to provide better quantitative image quality in the CNR analysis, allows surgeons to detect this improved image quality. Eventually this improved image quality should result in better decision-making during surgery about margins of excision and residual tumour resection.
Primary Safety Endpoint
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. The primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 45 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
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Exclusion Criteria:
SonoClear
Device: SonoClear ACF
The SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings
Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
To show that ultrasound images obtained when using SonoClear ACF are less influenced by image artefacts compared to images obtained when using routinely used saline solution measuring the contrast-to-noise ratio (CNR) in the images.
Time frame: During ultrasound guided brain tumour resection
Surgeons Image Rating (SIR) to assess the image quality
Quality assessment of the images is done by the core-lab in a blinded manner using the Surgeon Image Rating (SIR) scale, a 1-10 rating scale to score the quality of the image according to 3 questions at different time points during the operation. First timepoint being after craniotomy (no fluids involved). The second time point is when some tumour is left in the bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and the third time point being when the surgeon deems resection of the tumour to be completed.
Time frame: During ultrasound guided brain tumour resection
Adverse events up to 30 days post procedure
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. A primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
Time frame: safety data are collected up to 30 days post procedure
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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