Clinical trial NCT02105233: Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Glioma
Keywords: ultrasonography
ultrasonics
brain
surgery
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: National Competence Services for Ultrasound and Image-guided Therapy
name: SINTEF Health Research
First posted: 2014-04-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: adverse events
timeFrame: 1-72 hours
measure: adverse events
timeFrame: 1 month
measure: adverse events
timeFrame: 6 months
measure: adverse events
timeFrame: up to 6 months
Secondary outcomes:
measure: image quality
timeFrame: 1 day
measure: image signal-to-noise ratio
timeFrame: 1 day
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neurosurgery, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Geir Bråthen, phd md
role: STUDY_DIRECTOR
References: