Ultrasound Navigation Guided Improvement of High Grade Glioma Resection and Quality of Life: a phase III Randomized Controlled Trial.

Ultrasound Navigation Guided Improvement of High Grade Glioma Resection and Quality of Life: a phase III Randomized Controlled Trial. - US-GLIOMA Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41750

Enrollment

Registered

2015-12-28

Start date

2015-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

aggressive brain tumor high grade glioma

Interventions

High grade glioma

Quality of life

Ultrasound

The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .

Extent of resection

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Individuals between 18-75 years - Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma - KPS * 60 - Preoperative intention to perform gross-total resection of the enhancing tumor - Written informed consent conform ICH-GCP

Exclusion criteria

Exclusion criteria: - Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection - Multifocal contrast enhancing lesions - Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke) - Inability to give consent because of dysphasia or language barrier

Design outcomes

Primary

Measure	Time frame
Primarystudy parameter/endpoint * Extent of resection (gross-total resection or sub-total resection) Gross-total resection: No residual contrast enhancement on post-operative MRI scans (within 48 hours); 100% of all enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans. Sub-total resection: Residual contrast enhancement on post-operative MRI scans (within 48 hours);	—

Measure

Time frame

Primarystudy parameter/endpoint * Extent of resection (gross-total resection or sub-total resection) Gross-total resection: No residual contrast enhancement on post-operative MRI scans (within 48 hours); 100% of all enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans. Sub-total resection: Residual contrast enhancement on post-operative MRI scans (within 48 hours);

—

Secondary

Measure	Time frame
Secondary study parameters/endpoints * Extent of resection (%) Initial and residual tumor volume (cm3) of all enhancing tissue on respectively pre and post-operative MRI scans will be volumetrically assessed. The extent of resection (%) will be calculated with the formula: (initial tumor volume-residual tumor volume)/initial tumor volume x 100. * Neurological status (KPS) (Pre-operative and post-operative on 1, 3, 6 months) 32 * Quality of Life (QLQ-C30 and QLQ-BN 20 questionnaire) (Pre and post-operative on 1, 3, 6 months) * Surgery associated neurological deficits (National Institutes of Health Stroke Scale, NIHSS) (Pre-operative and 1 month post operative) * Adverse Events (classified according to the US National Cancer Institute common toxicity criteria version 4.0) * Time of survival (days)	—

Measure

Time frame

Secondary study parameters/endpoints * Extent of resection (%) Initial and residual tumor volume (cm3) of all enhancing tissue on respectively pre and post-operative MRI scans will be volumetrically assessed. The extent of resection (%) will be calculated with the formula: (initial tumor volume-residual tumor volume)/initial tumor volume x 100. * Neurological status (KPS) (Pre-operative and post-operative on 1, 3, 6 months) 32 * Quality of Life (QLQ-C30 and QLQ-BN 20 questionnaire) (Pre and post-operative on 1, 3, 6 months) * Surgery associated neurological deficits (National Institutes of Health Stroke Scale, NIHSS) (Pre-operative and 1 month post operative) * Adverse Events (classified according to the US National Cancer Institute common toxicity criteria version 4.0) * Time of survival (days)

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)