NCT03531333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

November 2, 2017

Last Update Submit

January 9, 2020

Conditions

Glioma

Keywords

Glioma, intraoperative ultrasound, gross total resection, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Extent of resection (%)

    within 48 hours after surgery

  • Neurological outcome (Karnofsky Performance status)

    within 1 week after surgery

  • Quality of Life (QLQ C30 questionnaires)

    1, 3 and 6 months after surgery

  • Quality of Life (QLQ BN20 questionnaires)

    1, 3 and 6 months after surgery

  • Surgery associated neurological deficits (National Institutes of Health Stroke Scale)

    1 month after surgery

  • +1 more secondary outcomes

Study Arms (2)

Ultrasound

EXPERIMENTAL

ultrasound navigation guided surgery.

Procedure: ultrasound guided surgery.

Non-ultrasound

NO INTERVENTION

standard surgery without ultrasound guidance.

Interventions

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.

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34094939DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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) .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurosurgeon, principal investigator

Study Record Dates

First Submitted

November 2, 2017

First Posted

May 21, 2018

Study Start

November 1, 2016

Primary Completion

December 31, 2019

Study Completion

August 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

NL(1)