Brain NeoplasmsPhase 1BMFNCT02105233
Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid
A Phase 1 study testing brain mimicking fluid in people with Brain Neoplasms and Glioma, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are increasing. 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?
- brain mimicking fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to May 2016
- Phase
- Phase 1
- 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 glioblastoma is suspected when there is a solitary brain tumour with ring-like contrast enhancement and oedema with no recent history (last 3 years) of primary tumour elsewhere
- 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. The fluid will only be used in cases where glioblastoma is suggested from this preliminary histopathological assessment.
Who cannot join
- Intended biopsy only (meaning: cases not suitable for resection)
- Other entities than glioblastoma is suspected
- Allergy to diary products and marine products
- Hypersensitvity to egg protein
- Hypersensitivity to soya or peanut protein
- Hypersensitvity to glycerol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Mimicking Fluid. Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid: a Preliminary Technical and Safety Study
Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. 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 the purpose of 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, potentially masking small tumor remnants and generally making the interpretation of images more difficult.
This research group has developed an acoustic 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. The investigators expect that the acoustic fluid will make it easier to detect small tumor remnants near the end of an operation, thus increasing success of glioma surgery. The purpose of this study is to test the fluid during surgery for histopathologically proven glioblastoma to assess safety and efficacy.
- Conditions
- Brain Neoplasms, Glioma
- Being tested
- brain mimicking fluid
- 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.
brain mimicking fluidBiological
Also called acoustic fluid
filled into the operation cavity during surgery for glioblastoma
| Study group | Role | What they receive |
|---|---|---|
| BMG | Experimental | brain mimicking fluid Receives: Biological: brain mimicking fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
All adverse events registered but with special emphasis on:
Intraoperatively -- epileptic seizures Immidiate postoperative -- hydrocephalus (MR images), imflammation of tissue that was in contact with AF (MR images)
Measured: 1-72 hours
adverse events
All adverse events registered but with special emphasis on:
hydrocephalus (MR images) inflammation (MR images)
Measured: 1 month
adverse events
All adverse events registered but with special emphasis on:
hydrocephalus (MR images), inflammation (MR images)
Measured: 6 months
adverse events
All adverse events registered but with special emphasis on:
unusual clinical events, neurological deterioration or reduced consciousness
Measured: up to 6 months
Secondary outcomes (2)
image quality
during the operation
- Qualitative score of ultrasound image quality (poor-medium-good)
- 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 posted7 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionMay 2016
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Competence Services for Ultrasound and Image-guided Therapy, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Geir Bråthen, phd md, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105233
- Sponsor's protocol ID
- 2012/1266
- Other IDs
- 2012-005567-27
- Acronym
- BMF
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2014
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mimicking Fluid. Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid: a Preliminary Technical and Safety Study
- ClinicalTrials.gov ID
- NCT02105233
- Acronym / sponsor ID
- BMF / 2012/1266
- Conditions
- Brain Neoplasms, Glioma
- Keywords
- ultrasonography, ultrasonics, brain, surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- National Competence Services for Ultrasound and Image-guided Therapy, SINTEF Health Research
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. 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 the purpose of 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, potentially masking small tumor remnants and generally making the interpretation of images more difficult.
This research group has developed an acoustic 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. The investigators expect that the acoustic fluid will make it easier to detect small tumor remnants near the end of an operation, thus increasing success of glioma surgery. The purpose of this study is to test the fluid during surgery for histopathologically proven glioblastoma to assess safety and efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMG | Experimental | Biological: brain mimicking fluidbrain mimicking fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A glioblastoma is suspected when there is a solitary brain tumour with ring-like contrast enhancement and oedema with no recent history (last 3 years) of primary tumour elsewhere
- 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. The fluid will only be used in cases where glioblastoma is suggested from this preliminary histopathological assessment.
Key exclusion criteria (6 listed)
- Intended biopsy only (meaning: cases not suitable for resection)
- Other entities than glioblastoma is suspected
- Allergy to diary products and marine products
- Hypersensitvity to egg protein
- Hypersensitivity to soya or peanut protein
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 |
|---|---|---|
| brain mimicking fluidAlso: acoustic fluidfilled into the operation cavity during surgery for glioblastoma | Biological | BMG |
Primary outcome
adverse events
Time frame: 1-72 hours
All adverse events registered but with special emphasis on: Intraoperatively -- epileptic seizures Immidiate postoperative -- hydrocephalus (MR images), imflammation of tissue that was in contact with AF (MR images)
adverse events
Time frame: 1 month
All adverse events registered but with special emphasis on: hydrocephalus (MR images) inflammation (MR images)
adverse events
Time frame: 6 months
All adverse events registered but with special emphasis on: hydrocephalus (MR images), inflammation (MR images)
adverse events
Time frame: up to 6 months
All adverse events registered but with special emphasis on: unusual clinical events, neurological deterioration or reduced consciousness
2 secondary outcomes
image quality
Time frame: 1 day
image signal-to-noise ratio
Time frame: 1 day
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 9 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.
Geir Bråthen, 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 1 study testing brain mimicking fluid 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 2 inclusion and 6 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 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
adverse events (time frame: 1-72 hours). The study lists 4 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 9 Apr 2019.