NCT03181581

Brief Summary

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 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. The artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult. This research group has developed an acoustic coupling 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. Three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. The concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase II study. This study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

June 2, 2017

Last Update Submit

April 8, 2019

Conditions

Brain NeoplasmsGlioma

Keywords

ultrasonographyultrasonicsbrainsurgery

Outcome Measures

Primary Outcomes (3)

  • difference in serious adverse event rates (test minus control)

    Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin

    72 hours

  • difference in serious adverse event rates (test minus control)

    Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin

    30 days

  • difference in serious adverse event rates (test minus control)

    Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin

    6 months

Secondary Outcomes (5)

  • image artefacts

    1 day

  • image artefacts

    1 day

  • depiction of outline of the anatomy surrounding the resection cavity

    1 day

  • depiction of outline of the anatomy surrounding the resection cavity

    1 day

  • image signal-to-noise ratio

    1 day

Other Outcomes (4)

  • Quality of Life

    1 month

  • Quality of Life

    1 month

  • Quality of Life

    6 months

  • +1 more other outcomes

Study Arms (4)

High grade gliomas stage 1 ACF

EXPERIMENTAL

In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group.

Biological: acoustic coupling fluid

Low-high grade gliomas stage 2 ACF

EXPERIMENTAL

If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma

Biological: acoustic coupling fluid

High grade gliomas stage 1 control

ACTIVE COMPARATOR

In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group.

Biological: Ringer's acetate

Low-high grade gliomas stage 2 control

ACTIVE COMPARATOR

If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma

Biological: Ringer's acetate

Interventions

acoustic coupling fluidBIOLOGICAL

ultrasound images obtained with both ACF and Ringer's acetate

Also known as: ACF
High grade gliomas stage 1 ACFLow-high grade gliomas stage 2 ACF
Ringer's acetateBIOLOGICAL

ultrasound images obtained with Ringer's acetate only

High grade gliomas stage 1 controlLow-high grade gliomas stage 2 control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).
  • 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 to confirm the diagnosis.
  • Karnofsky performance status \>=70

You may not qualify if:

  • Not able to consent (e.g. severe cognitive impairment)
  • Intended biopsy only (meaning: cases not suitable for resection)
  • Hypersensitivity to egg protein
  • Hypersensitivity to soya or peanut protein
  • Hypersensitivity to glycerol
  • Pregnancy of breast-feeding
  • Intention to become pregnant during the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Interventions

Ringer's acetate

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Petter Aadahl, phd md

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 9, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

NO(1)