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Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial. (US-GLIOMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531333
Recruitment Status : Unknown
Verified January 2020 by A.J.P.E. VIncent, Erasmus Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2018
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Stichting Coolsingel
Information provided by (Responsible Party):
A.J.P.E. VIncent, Erasmus Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioma Procedure: ultrasound guided surgery. Not Applicable

Detailed Description:

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:

  • Gross total resection (yes/no)
  • Extent of resection (%)
  • Neurological outcome (Karnofsky Performance Status)
  • Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)
  • Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
  • Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)
  • Survival time (days)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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) .
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound
ultrasound navigation guided surgery.
 Procedure: ultrasound guided surgery.
during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
No Intervention: Non-ultrasound
standard surgery without ultrasound guidance.


Outcome Measures
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Primary Outcome Measures :
  1. Gross total resection (Yes or No) [ Time Frame: within 48 hours after surgery ]
    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.


Secondary Outcome Measures :
  1. Extent of resection (%) [ Time Frame: within 48 hours after surgery ]
    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.

  2. Neurological outcome (Karnofsky Performance status) [ Time Frame: within 1 week after surgery ]
    Karnofsky Performance status

  3. Quality of Life (QLQ C30 questionnaires) [ Time Frame: 1, 3 and 6 months after surgery ]

    QLQ C30 questionnaires

    A brain tumor specific quality of life measurement tool


  4. Quality of Life (QLQ BN20 questionnaires) [ Time Frame: 1, 3 and 6 months after surgery ]

    QLQ BN20 questionnaires

    A brain tumor specific quality of life measurement tool


  5. Surgery associated neurological deficits (National Institutes of Health Stroke Scale) [ Time Frame: 1 month after surgery ]

    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.


  6. Survival (time in days) [ Time Frame: status will be checked 15 months after surgery ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals of 18 years or older
  • 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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531333


Locations
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Netherlands
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Stichting Coolsingel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: A.J.P.E. VIncent, neurosurgeon, principal investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03531333    
Other Study ID Numbers: MEC-2015-46
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A.J.P.E. VIncent, Erasmus Medical Center:
Glioma, intraoperative ultrasound, gross total resection, quality of life
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue