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

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.

Eligibility

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

Conditions4

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