Active not recruitingNAINTERVENTIONAL

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

This study is looking at a new fluid called SonoClear®, which is designed to make ultrasound images clearer during brain tumour surgery. Ultrasound uses sound waves to create pictures inside the body. During surgery, surgeons use these images to help them see the tumour and make sure they remove as much of it as possible. The main goal is to find out if SonoClear® is safe and if it can improve the quality of these ultrasound images compared to the usual fluids surgeons use. Better images could help doctors make more accurate decisions during the operation, potentially leading to a better outcome for patients. Patients with certain types of brain tumours (low-grade and high-grade gliomas) in Germany will be part of this study.

At a glance

Status

Active not recruiting

Phase

Sponsor

SonoClear AS

Enrolment target

Start

09 Feb 2026

Estimated completion

01 Nov 2026

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

What is this study about?

Imagine surgeons using a special camera during brain tumour surgery to see exactly where the tumour is. This 'camera' is an ultrasound machine, which uses sound waves to create live pictures inside the brain. These pictures help the surgeon decide how much of the tumour to remove.

During surgery, fluids are often used to help get better ultrasound images. This study is testing a new fluid called SonoClear® to see if it can improve these images even more. The idea is that if the ultrasound pictures are clearer, surgeons might be able to see the edges of the tumour better and remove more of it safely. This could potentially lead to better results for patients. The study wants to check if SonoClear® is both safe to use and if it actually makes the images better.

To do this, patients having surgery for certain brain tumours called gliomas will participate. During their operation, ultrasound images will be taken at different stages. Some images will be taken using the standard fluids, and others will be taken using SonoClear®. Doctors will then compare these images to see if SonoClear® helps create clearer pictures, making it easier for surgeons to judge what they are seeing. They will also keep a close eye on the patients to make sure the new fluid is safe.

Key takeaways

Tests a new fluid (SonoClear®) for clearer brain tumour ultrasound images.
Aims to help surgeons remove more of the tumour.
Compares SonoClear® to standard fluids during surgery.
Involves adults with low-grade or high-grade glioma.
Monitors patient safety and image quality for 6 months after surgery.
Participation includes checks during and after your planned surgery.

Who may be eligible?

To join this study, people must be at least 18 years old and have a specific type of brain tumour called a glioma (either low-grade or high-grade), which means they are already planning to have surgery to remove it. You also need to be reasonably fit for surgery, with a good overall health status.

There are also some reasons why you wouldn't be able to join. For example, if you can't understand or agree to take part, or if you've recently had certain brain infections (like meningitis) or radiation therapy to your brain. You also can't be in the study if you have a very weak immune system or if you're taking strong medicines that suppress your immune system.

Additionally, if you're pregnant, breastfeeding, or planning to become pregnant, you can't take part. It's also important that you don't have known allergies to certain ingredients like egg, soy, peanut protein, or glycerol.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a low-grade or high-grade glioma (a type of brain tumour) and are you having surgery for it?
Are you generally well enough for surgery?
Are you not pregnant, breastfeeding, or planning to become pregnant?
Do you not have a severe allergy to egg, soy, peanut protein, or glycerol?
Have you not had recent brain radiation or certain brain infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need extra tests or hospital visits outside of your planned brain tumour surgery. The study involves using the new SonoClear® fluid during your surgery itself. As part of your operation, the surgeons will take ultrasound pictures at different stages of the surgery, both with the usual fluids and with SonoClear®.

After your surgery, the study team will check up on you to see how you're doing. These check-ups will happen 72 hours, 30 days, and 6 months after your procedure. These are important for checking your safety and making sure there are no unexpected problems. The total duration of your involvement with the study will be about 6 months.

Potential risks and benefits

Taking part in this study may offer a potential benefit if the SonoClear® fluid helps surgeons get clearer images. This could, in turn, help them make better decisions during surgery about removing your tumour. However, we cannot guarantee any direct benefit to you. Potential risks are generally low, as the fluid is applied during surgery. We will be carefully monitoring your health for any side effects. You are always in control of your participation; you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Bezirkskrankenhaus Günzburg
Verified postcode
Günzburg, Germany
Universitätsklinikum Gießen und Marburg GmbH Standort Marburg
Verified postcode
Marburg, Germany
Eberhard Karls Universität Tübingen, Faculty of Medicine, Department of Neurosurgery
Verified postcode
Tübingen, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Verified postcode
Villingen-Schwenningen, Germany

Common questions

What is SonoClear®?

SonoClear® is a new fluid being tested to see if it can improve the quality of ultrasound images during brain tumour surgery.

What is a brain tumour ultrasound?

It's a way for surgeons to use sound waves during an operation to see live pictures inside your brain, helping them understand where the tumour is.

What kind of brain tumours are included?

This study is for adults with specific types of brain tumours called low-grade glioma (LGG) or high-grade glioma (HGG), including glioblastoma.

Will I get extra appointments if I join?

No, all study procedures happen during your planned surgery and during follow-up checks that are already part of your usual care, up to 6 months after surgery.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without giving a reason, and it will not affect your medical care.