Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.
NCT ID: NCT03181581
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2017-03-01
2018-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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High grade gliomas stage 1 ACF
In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group.
acoustic coupling fluid
ultrasound images obtained with both ACF and Ringer's acetate
Low-high grade gliomas stage 2 ACF
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
acoustic coupling fluid
ultrasound images obtained with both ACF and Ringer's acetate
High grade gliomas stage 1 control
In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group.
Ringer's acetate
ultrasound images obtained with Ringer's acetate only
Low-high grade gliomas stage 2 control
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
Ringer's acetate
ultrasound images obtained with Ringer's acetate only
Interventions
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acoustic coupling fluid
ultrasound images obtained with both ACF and Ringer's acetate
Ringer's acetate
ultrasound images obtained with Ringer's acetate only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy
UNKNOWN
SINTEF Health Research
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Petter Aadahl, phd md
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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Department of Neurosurgery, St Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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2016-003025-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACF-02
Identifier Type: -
Identifier Source: org_study_id
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