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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Olavs Hospital
Sponsor:
Collaborators:
National Competence Services for Ultrasound and Image-guided Therapy
SINTEF Health Research
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT02105233
First received: April 2, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Brain Neoplasms
Glioma
Biological: brain mimicking fluid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • adverse events [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]

    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)


  • adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    All adverse events registered but with special emphasis on:

    hydrocephalus (MR images) inflammation (MR images)


  • adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    All adverse events registered but with special emphasis on:

    hydrocephalus (MR images), inflammation (MR images)


  • adverse events [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

    All adverse events registered but with special emphasis on:

    unusual clinical events, neurological deterioration or reduced consciousness



Secondary Outcome Measures:
  • image quality [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    during the operation

    • Qualitative score of ultrasound image quality (poor-medium-good)
    • Qualitative score of artefacts in ultrasound images (none-some-much)

  • image signal-to-noise ratio [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)


Other Outcome Measures:
  • Quality of Life [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    assessed by EQ5D (generic) and QLQ-C30 (cancer specific)

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    assessed by EQ5D (generic) and QLQ-C30 (cancer specific)


Estimated Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMG
brain mimicking fluid
Biological: brain mimicking fluid
filled into the operation cavity during surgery for glioblastoma
Other Name: acoustic fluid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105233

Contacts
Contact: Asgeir S Jakola, phd md asgeir.s.jakola@ntnu.no

Locations
Norway
Department of Neurosurgery, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Asgeir S Jakola, phd md       asgeir.s.jakola@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
National Competence Services for Ultrasound and Image-guided Therapy
SINTEF Health Research
Investigators
Study Director: Geirmund Unsgård, phd md St. Olavs Hospital
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02105233     History of Changes
Other Study ID Numbers: 2012/1266, 2012-005567-27
Study First Received: April 2, 2014
Last Updated: April 2, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
ultrasonography
ultrasonics
brain
surgery

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014