Brain TumourNCT04734444
SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
A study testing SonoClear ACF in people with Brain Tumour and High Grade Glioma, run by SonoClear AS at 4 sites in 3 countries.
Trial 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-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumour, High Grade Glioma, Low-grade Glioma
- What is being tested?
- SonoClear ACF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Universitätsklinikum Ulm
Günzburg, 89312
Philipps-Universität Marburg
Marburg, 35037
About this study
Official title: Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
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.
Read the 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 bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and third timepoint being when the surgeon deems resection of the tumour to be completed. At the second and third timepoint ultrasound acquisition will be performed twice at each timepoint. Once with routinely used saline / Ringer's solution and once with SonoClear ACF.
There are two performance related primary endpoints, based on core lab assessments:
- To show that ultrasound images obtained with SonoClear ACF are less influenced by image artefacts compared to images obtained with standard of care saline or Ringer´s solution, by measuring the contrast-to-noise ratio (CNR). The CNR is a measure of the relative noise in the image. To achieve this endpoint, the use of SonoClear ACF must lead to superior image quality in comparison with Saline/Ringer´s solution. Superior image quality is defined as the CNR being statistically different between the images obtained with saline/Ringer and SonoClear ACF respectively, i.e., significantly less noise in the images obtained with SonoClear ACF.
- To show that ultrasound images obtained with SonoClear ACF are of better quality compared to images obtained with standard of care Saline/Ringer's solution, by using a qualitative assessment, called the Surgeons Image Rating (SIR) scale. A Panel of Experts will assess the quality of the obtained images by answering 3 questions for each image. The SIR a 1-10 numeric rating scale, is used to measure the quality of the image according to three questions to be answered at the three different timepoints during the operation.
This SIR is designed to explore whether SonoClear ACF, having shown to provide better quantitative image quality in the CNR analysis, allows surgeons to detect this improved image quality. Eventually this improved image quality should result in better decision-making during surgery about margins of excision and residual tumour resection.
Primary Safety Endpoint
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. The primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
- Conditions
- Brain Tumour, High Grade Glioma, Low-grade Glioma, Glioblastoma
- Being tested
- SonoClear ACF
- Keywords
- Acoustic Coupling Fluid (ACF), Ultrasound imaging in brain tumour surgery, brain tumour surgery
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoClear ACFDevice
The SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings
| Study group | Role | What they receive |
|---|---|---|
| SonoClear acoustic coupling fluid (ACF) mimicking brain tissue | Experimental | SonoClear Receives: Device: SonoClear ACF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
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.
Measured: During ultrasound guided brain tumour resection
Surgeons Image Rating (SIR) to assess the image quality
Quality assessment of the images is done by the core-lab in a blinded manner using the Surgeon Image Rating (SIR) scale, a 1-10 rating scale to score the quality of the image according to 3 questions at different time points during the operation. First timepoint being after craniotomy (no fluids involved). The second time point is when some tumour is left in the bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and the third time point being when the surgeon deems resection of the tumour to be completed.
Measured: During ultrasound guided brain tumour resection
Adverse events up to 30 days post procedure
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. A primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
Measured: safety data are collected up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, multi-centre single arm study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- SonoClear AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734444
- Sponsor's protocol ID
- ACF-03
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
- ClinicalTrials.gov ID
- NCT04734444
- Acronym / sponsor ID
- ACF-03
- Conditions
- Brain Tumour, High Grade Glioma, Low-grade Glioma, Glioblastoma
- Keywords
- Acoustic Coupling Fluid (ACF), Ultrasound imaging in brain tumour surgery, brain tumour surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SonoClear ASIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and third timepoint being when the surgeon deems resection of the tumour to be completed. At the second and third timepoint ultrasound acquisition will be performed twice at each timepoint. Once with routinely used saline / Ringer's solution and once with SonoClear ACF.
There are two performance related primary endpoints, based on core lab assessments:
- To show that ultrasound images obtained with SonoClear ACF are less influenced by image artefacts compared to images obtained with standard of care saline or Ringer´s solution, by measuring the contrast-to-noise ratio (CNR). The CNR is a measure of the relative noise in the image. To achieve this endpoint, the use of SonoClear ACF must lead to superior image quality in comparison with Saline/Ringer´s solution. Superior image quality is defined as the CNR being statistically different between the images obtained with saline/Ringer and SonoClear ACF respectively, i.e., significantly less noise in the images obtained with SonoClear ACF.
- To show that ultrasound images obtained with SonoClear ACF are of better quality compared to images obtained with standard of care Saline/Ringer's solution, by using a qualitative assessment, called the Surgeons Image Rating (SIR) scale. A Panel of Experts will assess the quality of the obtained images by answering 3 questions for each image. The SIR a 1-10 numeric rating scale, is used to measure the quality of the image according to three questions to be answered at the three different timepoints during the operation.
This SIR is designed to explore whether SonoClear ACF, having shown to provide better quantitative image quality in the CNR analysis, allows surgeons to detect this improved image quality. Eventually this improved image quality should result in better decision-making during surgery about margins of excision and residual tumour resection.
Primary Safety Endpoint
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. The primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, multi-centre single arm study
| Arm | Type | Receives |
|---|---|---|
| SonoClear acoustic coupling fluid (ACF) mimicking brain tissue | Experimental | Device: SonoClear ACFSonoClear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoClear ACFThe SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings | Device | SonoClear acoustic coupling fluid (ACF) mimicking brain tissue |
Primary outcome
Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise
Time frame: During ultrasound guided brain tumour resection
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.
Surgeons Image Rating (SIR) to assess the image quality
Time frame: During ultrasound guided brain tumour resection
Quality assessment of the images is done by the core-lab in a blinded manner using the Surgeon Image Rating (SIR) scale, a 1-10 rating scale to score the quality of the image according to 3 questions at different time points during the operation. First timepoint being after craniotomy (no fluids involved). The second time point is when some tumour is left in the bottom of the deeper part of the resection cavity (approximately 80% of tumour removed), and the third time point being when the surgeon deems resection of the tumour to be completed.
Adverse events up to 30 days post procedure
Time frame: safety data are collected up to 30 days post procedure
The primary safety hypothesis is to prove the primary safety event rate is less than 10%. A primary safety event is defined as any core lab determined major MRI finding when post-operative MRI is compared to pre-operative MRI that was found by the DMC to be serious and probably or definitely related to the study device OR any DMC determined serious adverse event that is probably or definitely related to the study device that occurs within 30 days of the procedure. Success is demonstrated by observing 0 of these events out of 37 subjects exposed to SonoClear ACF. This is equivalent to a two-sided p-value less 0.05 for the alternative hypothesis that the primary safety event rate in subjects undergoing tumor resection using ACF is less than 10%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoClear ACF in people with Brain Tumour and High Grade Glioma, run by SonoClear AS at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise (time frame: During ultrasound guided brain tumour resection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.