SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    20
  • sponsor
    SonoClear AS
Updated on 6 April 2022
karnofsky performance status
MRI

Summary

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 4 sites will be included. Additionally, safety data are collected up to 30 days post-procedure.

Description

The SonoClear ACF will be used in combination with conventional ultrasound imaging equipment, with the transducer positioned at the cortex or on top of the surgical entry point in the brain. Any CE-marked ultrasound system and transducer that can provide high-level image quality may be used.

The study is a pivotal single-arm trial in 3 or 4 centres on approximately 20 participants with either low grade (WHO Grade I/II) or high grade (WHO Grade III/IV) gliomas undergoing primary surgery, to collect performance and safety data on Sonoclear ACF in comparison with saline solution (the saline standard of care) as an acoustic coupling fluid during ultrasound imaging in brain surgery.

There are two primary performance outcomes, Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise and the Surgeons Image Rating (SIR) to assess the image quality and a primary safety outcome. The two primary performance outcomes will be addressed in a hierarchical gatekeeping approach. First, the SonoClear ACF will be tested for superiority over saline with respect to reduced image artefacts as detected by CNR. Besides the superiority of SonoClear ACF on CNR, it will be tested for superiority over saline using SIR. SIR is designed to assess if the expert panel, given an objective improvement in the quantitative CNR measures, can see a difference in image quality which potentially may help surgeons to deliver better excisional margins and more complete tumour resection (which might then lead to improved patient outcomes). By specifying this gatekeeping hierarchy, we present the two performance outcomes which are important clinically and in their logical order, and in such a way that the statistical chance of a false positive (a type 1 error) is still controlled at the usual 5% without the need for adjustment for multiple comparisons.

The primary analysis will be according to a modified Intention to Treat (mITT) set, which is a subset of the safety set and will include all participants who have a biopsy confirmed glioma and who have a complete set of interpretable images for each of the performance outcomes (i.e. an interpretable image on both SonoClear ACF and saline for both the CNR and the SIR outcomes showing the tumour).

The safety set will be defined as all participants who received at least one dose of SonoClear ACF.

Details
Condition Brain Tumour, High Grade Glioma, Low-grade Glioma, Glioblastoma
Treatment SonoClear ACF
Clinical Study IdentifierNCT04734444
SponsorSonoClear AS
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A diffuse malignant glial tumour (high (grade III and IV) or low grade (grade I-II) is suspected from the diagnostic MRI scan
A tumour that extends at least 3 cm in depth from the surface of the brain (confirmed by MRI)
Pre- or peri-procedural confirmed histopathology of glioma
≥18 years of age
Karnofsky performance status ≥ 70
Life expectancy of more than 30 days at the time of the procedure
Negative pregnancy test for female subjects of childbearing potential

Exclusion Criteria

Not able to give consent (e.g. severe cognitive impairment)
History of brain radiation therapy
Recent meningitis (within 6 months prior to screening visit)
Other active infection (within 30 days prior to screening visit)
Immuno-incompetent patient (e.g. failing immune system due to AIDS)
Patients taking immune-suppressive medication
Intended biopsy only (meaning: cases not suitable for resection)
Known hypersensitivity to egg protein
Known hypersensitivity to soybean or peanut protein
Known Hypersensitivity to glycerol
Known Hypersensitivity to polysorbates
Pregnant or lactating females or females who intend to become pregnant during the time of the study
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