A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery

NCT07042620 | Recruiting DMC

• 1 other identifier: ACF-03-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this clinical investigation is to assess the safety and performance of the SonoClear® System. 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 the SonoClear® System relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of high-grade glioma (HGG) and low-grade glioma (LGG) at up to 5 sites in Germany will be included. Additionally, safety data are collected at 72 hours, 30 days and 6 months post procedure.

Conditions

Low Grade Glioma (LGG), High Grade Glioma (HGG); Brain Tumor Adult; Glioblastoma

Keywords

Acoustic Coupling Fluid; 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 the SonoClear(R) System 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.

  Ultrasound guided brain tumor resection procedure/surgery

• 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.

  Ultrasound guided brain tumor resection procedure/surgery

• Adverse events up to 6 months post procedure

  The primary safety hypothesis declared in ACF-03 study is to prove the primary safety event rate is less than 10%. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear® ACF, i.e. the event rate is 0% with an upper two-sided 95% confidence limit less than 10%. With an event rate of less than 10% for major neurotoxicity events that are serious and probably or definitely related to the device, the benefit of a clearer image for the neurosurgeon balances the potentially increased risk. This study expands the number of patients to evaluate the safety outcome. The primary safety event rate will be evaluated also in a total group of 60 patients, 45 using SonoClear® ACF and 15 using the SonoClear® System.

  safety data are collected up to 6 months post procedure

Study Arms (1)

Ultrasound imaging in brain tumour surgery with the use of SonoClear® System mimicking brain tissue.

EXPERIMENTAL

SonoClear(R) System

Device: SonoClear(R) System

Interventions

SonoClear(R) System DEVICE

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

Ultrasound imaging in brain tumour surgery with the use of SonoClear® System 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 (grade III and IV) or low grade (grade I-II)) is suspected from the diagnostic MRI scan
• 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 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
• 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)

Bezirkskrankenhaus Günzburg

Günzburg, 89312, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg GmbH Standort Marburg

Marburg, 35033, Germany

RECRUITING

Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery

Tübingen, 72076, Germany

RECRUITING

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

RECRUITING

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Helene Quie

CONTACT

+45 5664 1010; helene@sonoclear.no

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: June 12, 2025
• First Posted: June 29, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)