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| Name | Class |
|---|---|
| Stichting Coolsingel | UNKNOWN |
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The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
Study design:
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
Study population:
Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.
Intervention:
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Main study parameters/endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | ultrasound navigation guided surgery. |
|
| Non-ultrasound | No Intervention | standard surgery without ultrasound guidance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guided surgery. | Procedure | during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Gross total resection (Yes or No) | Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans. | within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of resection (%) | as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume. | within 48 hours after surgery |
| Neurological outcome (Karnofsky Performance status) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34094939 | Derived | Incekara F, Smits M, Dirven L, Bos EM, Balvers RK, Haitsma IK, Schouten JW, Vincent AJPE. Intraoperative B-Mode Ultrasound Guided Surgery and the Extent of Glioblastoma Resection: A Randomized Controlled Trial. Front Oncol. 2021 May 19;11:649797. doi: 10.3389/fonc.2021.649797. eCollection 2021. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
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Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.
Karnofsky Performance status |
| within 1 week after surgery |
| Quality of Life (QLQ C30 questionnaires) | QLQ C30 questionnaires A brain tumor specific quality of life measurement tool | 1, 3 and 6 months after surgery |
| Quality of Life (QLQ BN20 questionnaires) | QLQ BN20 questionnaires A brain tumor specific quality of life measurement tool | 1, 3 and 6 months after surgery |
| Surgery associated neurological deficits (National Institutes of Health Stroke Scale) | National Institutes of Health Stroke Scale 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions. | 1 month after surgery |
| Survival (time in days) | time measured from surgery until death in days. This study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data. | status will be checked 15 months after surgery |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |