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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02105233
First Posted: April 7, 2014
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Competence Services for Ultrasound and Image-guided Therapy
SINTEF Health Research
Information provided by (Responsible Party):
St. Olavs Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

    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 ]

    All adverse events registered but with special emphasis on:

    hydrocephalus (MR images) inflammation (MR images)


  • adverse events [ Time Frame: 6 months ]

    All adverse events registered but with special emphasis on:

    hydrocephalus (MR images), inflammation (MR images)


  • adverse events [ Time Frame: up to 6 months ]

    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 ]

    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 ]
    after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)


Other Outcome Measures:
  • Quality of Life [ Time Frame: 1 month ]
    assessed by EQ5D (generic) and QLQ-C30 (cancer specific)

  • Quality of Life [ Time Frame: 6 months ]
    assessed by EQ5D (generic) and QLQ-C30 (cancer specific)


Enrollment: 15
Study Start Date: February 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105233


Locations
Norway
Department of Neurosurgery, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
National Competence Services for Ultrasound and Image-guided Therapy
SINTEF Health Research
Investigators
Study Director: Geir Bråthen, 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 ( EudraCT Number )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Last Update Posted: May 19, 2016
Last Verified: May 2016

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