SonoClear® acoustic coupling fluid to improve ultrasound imaging during brain tumor surgery
Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear® System Mimicking Brain Tissue.
This will test whether the SonoClear® fluid gives clearer intraoperative ultrasound images for adults undergoing glioma resection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SonoClear AS Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Günzburg and 3 other locations) |
| Trial ID | NCT07042620 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-centre single-arm study in which each patient serves as their own control to compare SonoClear® against routinely used irrigation fluids. Ultrasound images are taken at multiple operative timepoints (after craniotomy, during partial resection, and at presumed completion), with paired acquisitions using standard fluids and SonoClear®. Image performance is measured quantitatively by contrast-to-noise ratio (CNR) and qualitatively by a Surgeons Image Rating (SIR) scale scored by a core lab panel. Safety data are collected at 72 hours, 30 days, and 6 months after the procedure at participating German centers.
Who should consider this trial
Good fit: Adults (≥18) with suspected or histologically confirmed low- or high-grade diffuse glioma who are planned for surgical resection, have a Karnofsky performance status ≥70, and life expectancy >30 days are appropriate candidates.
Not a fit: Patients planned for biopsy only, those with prior brain radiation, severe cognitive impairment preventing informed consent, or known hypersensitivity to the fluid components are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, SonoClear® could provide clearer ultrasound images that help surgeons identify residual tumor and improve completeness of resection.
How similar studies have performed: Preclinical work and small clinical reports indicate specialized coupling fluids can reduce ultrasound artefacts, but robust multicentre clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key 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 * Pregnant or lactating females or females who intend to become pregnant during the time of the study
Where this trial is running
Günzburg and 3 other locations
- Bezirkskrankenhaus Günzburg — Günzburg, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH Standort Marburg — Marburg, Germany (Recruiting)
- Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery — Tübingen, Germany (Recruiting)
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH — Villingen-Schwenningen, Germany (Recruiting)
Study contacts
- Study coordinator: Helene Quie
- Email: helene@sonoclear.no
- Phone: +45 5664 1010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.