Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.

Glioma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03181581
• Other study ID #: ACF-02
• Secondary ID: 2016-003025-42
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma

Intervention

Biological:
• acoustic coupling fluid
ultrasound images obtained with both ACF and Ringer's acetate
• Ringer's acetate
ultrasound images obtained with Ringer's acetate only

Locations

Country	Name	City	State
Norway	Department of Neurosurgery, St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy, SINTEF Health Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	assessed by EQ5D (generic)	1 month
Other	Quality of Life	assessed by QLQ-C30 (cancer specific)	1 month
Other	Quality of Life	assessed by EQ5D (generic)	6 months
Other	Quality of Life	assessed by QLQ-C30 (cancer specific)	6 months
Primary	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	72 hours
Primary	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	30 days
Primary	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	6 months
Secondary	image artefacts	during the operation; Qualitative score of ultrasound image quality (poor-medium-good)	1 day
Secondary	image artefacts	during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)	1 day
Secondary	depiction of outline of the anatomy surrounding the resection cavity	during the operation; Qualitative score of ultrasound image quality (poor-medium-good)	1 day
Secondary	depiction of outline of the anatomy surrounding the resection cavity	during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)	1 day
Secondary	image signal-to-noise ratio	after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)	1 day