Clinical trial · Interventional
A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery
Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear® System 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® 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.
Conditions
Conditions (3)
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 Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Low Grade Glioma (LGG), High Grade Glioma (HGG) | Glioma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SonoClear(R) System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrasound imaging in brain tumour surgery with the use of SonoClear® System mimicking brain tissue.
- description
- SonoClear(R) System
- interventionNames
- Device: SonoClear(R) System
Primary outcomes (3)
- measure
- Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
- timeFrame
- Ultrasound guided brain tumor resection procedure/surgery
- description
- To show that ultrasound images obtained when using the SonoClear(R) System 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
- Ultrasound guided brain tumor resection procedure/surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available