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NCT Number: NCT01394692

Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, Goethe-University

Frankfurt, 60528, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • known or suspected contrast-enhancing glioma (primary and recurrent)
  • location of the tumor permits intended gross-total resection

Exclusion criteria

  • tumor location prohibits or questions gross-total resection
  • contraindications to undergo MRI examinations

Treatment and study plan

intraoperative MRI-guided tumor resection

Procedure

tumor resection with the use of an intraoperative MRI

Other names: PoleStar-N20 intraoperative MRI

standard microsurgery

Procedure

microsurgical tumor resection

Primary outcomes

  1. Extent of Resection

    Time frame: 72 hours

    Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved

Secondary outcomes

  1. Progression-free Survival

    Time frame: 6 months

    Progression-free survival (radiological and/or clinical progression) at 6 months following surgery

  2. Volumetric Assessment

    Time frame: 72 hours

    Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI

  3. Neurological Deficit

    Time frame: 7 days

    Assessment of new postoperative deficits following tumor surgery

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jul 14, 2011
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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