Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumour | Brain Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
| Low-grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SonoClear ACF | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SonoClear acoustic coupling fluid (ACF) mimicking brain tissue
- description
- SonoClear
- interventionNames
- Device: SonoClear ACF
Primary outcomes (3)
- measure
- Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
- timeFrame
- During ultrasound guided brain tumour resection
- description
- To show that ultrasound images obtained when using SonoClear ACF 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.
- measure
- Surgeons Image Rating (SIR) to assess the image quality
- timeFrame
- During ultrasound guided brain tumour resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 * Known Hypersensitivity to polysorbates * Pregnant or lactating females or females who intend to become pregnant during the time of the study
References
Publications (0)
Data not yet available