NCT04734444Completed
SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 22 Jan 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- SonoClear AS
- Diseases
- Glioblastoma
- NCT number
- NCT04734444
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 1 Sept 2021 to the primary completion date, 31 Dec 2024
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent meningitis (within 6 months prior to screening visit)
- Other active infection (within 30 days prior to screening visit)
- Patients taking immune-suppressive medication
- Intended biopsy only (meaning: cases not suitable for resection)
Other illness
- Not able to give consent (e.g. severe cognitive impairment)
- History of brain radiation therapy
- Known hypersensitivity to egg protein
- Known hypersensitivity to soybean or peanut protein
- Known Hypersensitivity to glycerol
- Known Hypersensitivity to polysorbates
Other
- Immuno-incompetent patient (e.g. failing immune system due to AIDS)
- Pregnant or lactating females or females who intend to become pregnant during the time of the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Günzburg | Germany | Unknown status |
| Philipps-Universität Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Instituto Neurologico "C. Besta" Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.