Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid (BMF)

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.

Study Overview

• Status: Completed
• Conditions: Glioma; Brain Neoplasms
• Intervention / Treatment: Biological: brain mimicking fluid

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Department of Neurosurgery, St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMG; brain mimicking fluid	Biological: brain mimicking fluid; filled into the operation cavity during surgery for glioblastoma; Other Names: acoustic fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1-72 hours
adverse events	All adverse events registered but with special emphasis on: hydrocephalus (MR images) inflammation (MR images)	1 month
adverse events	All adverse events registered but with special emphasis on: hydrocephalus (MR images), inflammation (MR images)	6 months
adverse events	All adverse events registered but with special emphasis on: unusual clinical events, neurological deterioration or reduced consciousness	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image signal-to-noise ratio	after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)	1 day
image quality	during the operation; Qualitative score of ultrasound image quality (poor-medium-good); Qualitative score of artefacts in ultrasound images (none-some-much)	1 day

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: SINTEF Health Research; National Competence Services for Ultrasound and Image-guided Therapy
• Investigators: Study Director: Geir Bråthen, phd md, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: surgery; brain; ultrasonography; ultrasonics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 2012/1266; 2012-005567-27 (EudraCT Number)