A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultra… (NCT07042620) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery
Germany15 participantsStarted 2026-02-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new fluid to improve ultrasound image quality during brain tumor surgery — can you explain how better ultrasound imaging during my surgery could affect decisions the surgeon makes in real time, and whether that matters for my specific tumor type?
2Since this trial is listed as 'active but not longer recruiting,' is there any chance I could still be considered for participation, or is it completely closed to new patients?
3The trial is tracking adverse events for up to 6 months after the procedure — what kinds of risks or side effects are associated with this type of imaging fluid being used in or near the brain during surgery, and how do they compare to standard surgical imaging approaches?
4This study covers both low-grade and high-grade gliomas, including glioblastoma — given my specific diagnosis, would the potential benefit of improved intraoperative ultrasound imaging be meaningful for my case, or is it more relevant for certain tumor types than others?
5Since this is listed as Phase NA, meaning it may not follow the traditional phase structure, what does that tell us about how much is already known about the safety and effectiveness of this fluid, and should that influence how I think about it as an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise