Intra-operative functional Ultrasound (fUS)-imaging during spinal cord tumor removal surgery

Intra-operative functional Ultrasound (fUS)-imaging during spinal cord tumor removal surgery - fUS-SPINE Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55486

Enrollment

Registered

2021-03-10

Start date

2021-05-03

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intramedullaire tumor Ruggenmergtumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Undergoing spinal cord tumor removal surgery with the use of intra-operative neuro-monitoring (IONM) - Age > 18 years - Mentally competent

Exclusion criteria

Exclusion criteria: - Depression or an anxiety disorder

Design outcomes

Primary

Measure	Time frame
The primary study parameter is a measure comparing functionality as defined by IONM with functionality as defined by fUS, hereon referred to as the fUS- accuracy, which is defined as the percentage of imaging trials with functional IONM-signal which also presented with functional signal using fUS. To determine this parameter, we will have to undergo a multi-phase process. Firstly, we will use the standard IONM-technique to roughly indicate whether the spinal cord tissue is still functionally intact or not (based on the different functionalities represented by the different stimulation paradigms). Secondly, we will determine whether we can also detect functional signal in the fUS-acquired images. For this we will use the mean correlation value ('r'), also known as the Pearson Correlation Coefficient. For every tested electrical stimulation pattern, the mean correlation between the stimulation pattern and the Doppler signal is calculated along with the mean correlation calculated outside the functional area as a reference correlation value.	—

Measure

Time frame

The primary study parameter is a measure comparing functionality as defined by IONM with functionality as defined by fUS, hereon referred to as the *fUS- accuracy*, which is defined as the percentage of imaging trials with functional IONM-signal which also presented with functional signal using fUS. To determine this parameter, we will have to undergo a multi-phase process. Firstly, we will use the standard IONM-technique to roughly indicate whether the spinal cord tissue is still functionally intact or not (based on the different functionalities represented by the different stimulation paradigms). Secondly, we will determine whether we can also detect functional signal in the fUS-acquired images. For this we will use the mean correlation value ('r'), also known as the Pearson Correlation Coefficient. For every tested electrical stimulation pattern, the mean correlation between the stimulation pattern and the Doppler signal is calculated along with the mean correlation calculated outside the functional area as a reference correlation value.

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Secondary

Measure	Time frame
As a secondary study parameter we will also asses the ability of fUS to distinguish healthy from tumor tissue by comparing and contrasting intra-operative microDopples images of the SCBV of both healthy and tumor tissue.	—

Countries

Netherlands

Outcome results