Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.

Sponsor

St. Olavs Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03181581

Collaborator

Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy (Other), SINTEF Health Research (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasms Glioma	Biological: acoustic coupling fluid Biological: Ringer's acetate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue: a Phase II Technical and Safety Study

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High grade gliomas stage 1 ACF 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 ultrasound images obtained with both ACF and Ringer's acetate Other Names: ACF
Experimental: Low-high grade gliomas stage 2 ACF 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 ultrasound images obtained with both ACF and Ringer's acetate Other Names: ACF
Active Comparator: High grade gliomas stage 1 control 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 ultrasound images obtained with Ringer's acetate only
Active Comparator: Low-high grade gliomas stage 2 control 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 ultrasound images obtained with Ringer's acetate only

Outcome Measures

Primary Outcome Measures

difference in serious adverse event rates (test minus control) [72 hours]
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
difference in serious adverse event rates (test minus control) [30 days]
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
difference in serious adverse event rates (test minus control) [6 months]
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

Secondary Outcome Measures

image artefacts [1 day]
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
image artefacts [1 day]
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
depiction of outline of the anatomy surrounding the resection cavity [1 day]
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
depiction of outline of the anatomy surrounding the resection cavity [1 day]
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
image signal-to-noise ratio [1 day]
after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)

Other Outcome Measures

Quality of Life [1 month]
assessed by EQ5D (generic)
Quality of Life [1 month]
assessed by QLQ-C30 (cancer specific)
Quality of Life [6 months]
assessed by EQ5D (generic)
Quality of Life [6 months]
assessed by QLQ-C30 (cancer specific)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

St. Olavs Hospital
Norwegian National Advisory Unit for Ultrasound and Image-guided Therapy
SINTEF Health Research

Investigators

Study Director: Petter Aadahl, phd md, St. Olavs Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

St. Olavs Hospital

ClinicalTrials.gov Identifier:

NCT03181581

Other Study ID Numbers:

ACF-02
2016-003025-42

First Posted:

Jun 9, 2017

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by St. Olavs Hospital

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Apr 10, 2019