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

Glioma Clinical Trial

— BMF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105233
• Other study ID #: 2012/1266
• Secondary ID: 2012-005567-27
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Est. completion date: May 2016

Study information

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

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma

Intervention

Biological:
• brain mimicking fluid
filled into the operation cavity during surgery for glioblastoma

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	National Competence Services for Ultrasound and Image-guided Therapy, SINTEF Health Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	adverse events	All adverse events registered but with special emphasis on: hydrocephalus (MR images) inflammation (MR images)	1 month
Primary	adverse events	All adverse events registered but with special emphasis on: hydrocephalus (MR images), inflammation (MR images)	6 months
Primary	adverse events	All adverse events registered but with special emphasis on: unusual clinical events, neurological deterioration or reduced consciousness	up to 6 months
Secondary	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
Secondary	image signal-to-noise ratio	after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)	1 day