SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue

NCT04734444 | Completed DMC

• 1 other identifier: ACF-03
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 4

Brief 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 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.

Conditions

Brain Tumour; High Grade Glioma; Low-grade Glioma; Glioblastoma

Keywords

Acoustic Coupling Fluid (ACF); Ultrasound imaging in brain tumour surgery; brain tumour surgery

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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%.

  safety data are collected up to 30 days post procedure

Study Arms (1)

SonoClear acoustic coupling fluid (ACF) mimicking brain tissue

EXPERIMENTAL

SonoClear

Device: SonoClear ACF

Interventions

SonoClear ACF DEVICE

The SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings

SonoClear acoustic coupling fluid (ACF) mimicking brain tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SonoClear AS: lead

Study Sites (4)

Universitätsklinikum Ulm

Günzburg, 89312, Germany

Location

Philipps-Universität Marburg

Marburg, 35037, Germany

Location

Instituto Neurologico "C. Besta"

Milan, 20133, Italy

Location

University Hospital Bratislava

Bratislava, 83305, Slovakia

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The following measures have been taken to minimize or avoid bias: * Core-lab evaluation of the CNR outcome in a blinded fashion * SIR clinical rating of US images by an independent expert panel in a blinded fashion Due to the nature of brain surgery and the diversity of the tumours, it is seen as a strength to the trial that the patient can act as its own control even though the images can never be 100% the same in the separate image acquisition. This is especially true for 2D US images, whereas with a 3D US image it is more likely to obtain the same position for sequential image acquisition.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multi-centre single arm study

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 2, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); IT (1); SL (1)