Status:
COMPLETED
SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
Lead Sponsor:
SonoClear AS
Conditions:
Brain Tumour
High Grade Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-noi...
Detailed Description
Ultrasound images will be obtained at different timepoints during the operation. First timepoint being after craniotomy (no fluids involved). Second timepoint being when some tumour is left in the bot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04734444
Start Date
September 1 2021
End Date
December 31 2024
Last Update
June 17 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Ulm
Günzburg, Germany, 89312
2
Philipps-Universität Marburg
Marburg, Germany, 35037
3
Instituto Neurologico "C. Besta"
Milan, Italy, 20133
4
University Hospital Bratislava
Bratislava, Slovakia, 83305