Brain NeoplasmsPhase 2NCT03181581
Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.
A Phase 2 study testing acoustic coupling fluid and Ringer's acetate in people with Brain Neoplasms and Glioma, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Glioma
- What is being tested?
- acoustic coupling fluid and Ringer's acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2017to 31 Dec 2018
- Phase
- Phase 2
- 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 glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).
- In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis.
- Karnofsky performance status >=70
Who cannot join
- Not able to consent (e.g. severe cognitive impairment)
- Intended biopsy only (meaning: cases not suitable for resection)
- Hypersensitivity to egg protein
- Hypersensitivity to soya or peanut protein
- Hypersensitivity to glycerol
- Pregnancy of breast-feeding
- Intention to become pregnant during the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue: a Phase II Technical and Safety Study
Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.
Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult.
This research group has developed an acoustic coupling fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.
- Conditions
- Brain Neoplasms, Glioma
- Being tested
- acoustic coupling fluid, Ringer's acetate
- Keywords
- ultrasonography, ultrasonics, brain, surgery
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustic coupling fluidBiological
Also called ACF
ultrasound images obtained with both ACF and Ringer's acetate
Ringer's acetateBiological
ultrasound images obtained with Ringer's acetate only
| Study group | Role | What they receive |
|---|---|---|
| High grade gliomas stage 1 ACF | Experimental | In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group. Receives: Biological: acoustic coupling fluid |
| Low-high grade gliomas stage 2 ACF | Experimental | If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma Receives: Biological: acoustic coupling fluid |
| High grade gliomas stage 1 control | Active comparator | In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group. Receives: Biological: Ringer's acetate |
| Low-high grade gliomas stage 2 control | Active comparator | If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma Receives: Biological: Ringer's acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Measured: 72 hours
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Measured: 30 days
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Measured: 6 months
Secondary outcomes (5)
image artefacts
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Measured: 1 day
image artefacts
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
Measured: 1 day
depiction of outline of the anatomy surrounding the resection cavity
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Measured: 1 day
depiction of outline of the anatomy surrounding the resection cavity
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
Measured: 1 day
image signal-to-noise ratio
after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: because the study had to be redesigned and restarted as clinical device study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Petter Aadahl, phd md, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181581
- Sponsor's protocol ID
- ACF-02
- Other IDs
- 2016-003025-42, 2016
- Status last verified
- Apr 2019
- First submitted
- 2 Jun 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue: a Phase II Technical and Safety Study
- ClinicalTrials.gov ID
- NCT03181581
- Acronym / sponsor ID
- ACF-02
- Conditions
- Brain Neoplasms, Glioma
- Keywords
- ultrasonography, ultrasonics, brain, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because the study had to be redesigned and restarted as clinical device study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy, SINTEF Health Research
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jun 2017 (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.
Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival.
Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization and resection control. For the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. However, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult.
This research group has developed an acoustic coupling fluid intended for use in the resection cavity instead of saline. Tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High grade gliomas stage 1 ACF | Experimental | Biological: acoustic coupling fluidIn the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group. |
| Low-high grade gliomas stage 2 ACF | Experimental | Biological: acoustic coupling fluidIf the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma |
| High grade gliomas stage 1 control | Active comparator | Biological: Ringer's acetateIn the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group. |
| Low-high grade gliomas stage 2 control | Active comparator | Biological: Ringer's acetateIf the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).
- In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis.
- Karnofsky performance status >=70
Key exclusion criteria (7 listed)
- Not able to consent (e.g. severe cognitive impairment)
- Intended biopsy only (meaning: cases not suitable for resection)
- Hypersensitivity to egg protein
- Hypersensitivity to soya or peanut protein
- Hypersensitivity to glycerol
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 |
|---|---|---|
| acoustic coupling fluidAlso: ACFultrasound images obtained with both ACF and Ringer's acetate | Biological | High grade gliomas stage 1 ACF, Low-high grade gliomas stage 2 ACF |
| Ringer's acetateultrasound images obtained with Ringer's acetate only | Biological | High grade gliomas stage 1 control, Low-high grade gliomas stage 2 control |
Primary outcome
difference in serious adverse event rates (test minus control)
Time frame: 72 hours
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
difference in serious adverse event rates (test minus control)
Time frame: 30 days
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
difference in serious adverse event rates (test minus control)
Time frame: 6 months
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
5 secondary outcomes
image artefacts
Time frame: 1 day
image artefacts
Time frame: 1 day
depiction of outline of the anatomy surrounding the resection cavity
Time frame: 1 day
depiction of outline of the anatomy surrounding the resection cavity
Time frame: 1 day
image signal-to-noise ratio
Time frame: 1 day
Results and safety
The study was stopped early (reason given: because the study had to be redesigned and restarted as clinical device study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Petter Aadahl, phd md study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acoustic coupling fluid and Ringer's acetate in people with Brain Neoplasms and Glioma, run by St. Olavs Hospital at 1 site in Norway.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: because the study had to be redesigned and restarted as clinical device study). Results are not available in the source record.
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?
difference in serious adverse event rates (test minus control) (time frame: 72 hours). 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 10 Apr 2019.