Department of Neurosurgery, St Olavs Hospital
Trondheim, Norway
NCT Number: NCT02105233
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Trondheim, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
filled into the operation cavity during surgery for glioblastoma
Other names: acoustic fluid
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)
Time frame: 1 month
All adverse events registered but with special emphasis on:
hydrocephalus (MR images) inflammation (MR images)
Time frame: 6 months
All adverse events registered but with special emphasis on:
hydrocephalus (MR images), inflammation (MR images)
Time frame: up to 6 months
All adverse events registered but with special emphasis on:
unusual clinical events, neurological deterioration or reduced consciousness
Time frame: 1 day
during the operation
Time frame: 1 day
after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)
St. Olavs Hospital
Other
Brain Mimicking Fluid. Improving Ultrasound Images in Brain Tumor Surgery With the Use of Brain Mimicking Fluid: a Preliminary Technical and Safety Study
Acronym: BMF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07238322
Brain Diseases, Brain Neoplasms
San Francisco, California, United States
View Trial DetailsNCT06322342
Acoustic Neuroma, Autoimmune Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT05062772
Astrocytoma, Brain Cancer
Boston, Massachusetts, United States
View Trial DetailsNCT00038441
Brain Diseases, Brain Neoplasms
Houston, Texas, United States
View Trial Details