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

NCT02105233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-04-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

brain mimicking fluid

filled into the operation cavity during surgery for glioblastoma

Sponsors & Collaborators

  • National Competence Services for Ultrasound and Image-guided Therapy

    collaborator UNKNOWN

  • SINTEF Health Research

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Geir Bråthen, phd md · St. Olavs Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105233 on ClinicalTrials.gov