A Phase 2 interventional study of acoustic coupling fluid and Ringer's acetate in Brain Neoplasms and Glioma, sponsored by St. Olavs Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by St. Olavs Hospital · Phase 2, Interventional, and Diagnostic
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group.
Biological: acoustic coupling fluid
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
Biological: acoustic coupling fluid
In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group.
Biological: Ringer's acetate
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
Biological: Ringer's acetate
ultrasound images obtained with both ACF and Ringer's acetate
Also known as: ACF
ultrasound images obtained with Ringer's acetate only
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
Time frame: 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
Time frame: 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
Time frame: 6 months
image artefacts
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Time frame: 1 day
image artefacts
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
Time frame: 1 day
depiction of outline of the anatomy surrounding the resection cavity
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Time frame: 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)
Time frame: 1 day
image signal-to-noise ratio
after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)
Time frame: 1 day
Quality of Life
assessed by EQ5D (generic)
Time frame: 1 month
Quality of Life
assessed by QLQ-C30 (cancer specific)
Time frame: 1 month
Quality of Life
assessed by EQ5D (generic)
Time frame: 6 months
Quality of Life
assessed by QLQ-C30 (cancer specific)
Time frame: 6 months
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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