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

NCT02105233 | Completed Phase 1 DMC

• 2 other identifiers: 2012/12662012-005567-27
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Neoplasms; Glioma

Keywords

ultrasonography; ultrasonics; brain; surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• image quality

  1 day

• image signal-to-noise ratio

  1 day

Study Arms (1)

BMG

EXPERIMENTAL

brain mimicking fluid

Biological: brain mimicking fluid

Interventions

brain mimicking fluid BIOLOGICAL

filled into the operation cavity during surgery for glioblastoma

Also known as: acoustic fluid

BMG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• National Competence Services for Ultrasound and Image-guided Therapy: collaborator
• SINTEF Health Research: collaborator

Study Sites (1)

Department of Neurosurgery, St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Geir Bråthen, phd md

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

NO (1)