NCT01394692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 28, 2012

Completed
Last Updated

November 28, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

July 13, 2011

Results QC Date

September 20, 2012

Last Update Submit

October 29, 2012

Conditions

Glioma

Keywords

intraoperative MRIglioma surgeryextent of resection

Outcome Measures

Primary Outcomes (1)

  • Extent of Resection

    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

    72 hours

Secondary Outcomes (3)

  • Progression-free Survival

    6 months

  • Volumetric Assessment

    72 hours

  • Neurological Deficit

    7 days

Study Arms (2)

intraoperative MRI

ACTIVE COMPARATOR

tumor resection with intraoperative MRI-guidance

Procedure: intraoperative MRI-guided tumor resection

conventional group

ACTIVE COMPARATOR

standard microsurgical tumor resection

Procedure: standard microsurgery

Interventions

intraoperative MRI-guided tumor resectionPROCEDURE

tumor resection with the use of an intraoperative MRI

Also known as: PoleStar-N20 intraoperative MRI
intraoperative MRI
standard microsurgeryPROCEDURE

microsurgical tumor resection

conventional group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Goethe-University

Frankfurt, 60528, Germany

Location

Related Publications (1)

  • Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.

    PMID: 21868284RESULT

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Christian Senft
Organization
Johann Wolfgang Goethe University
c.senft@med.uni-frankfurt.de
+49 69 63015939

Study Officials

  • Christian Senft, M.D.

    Goethe University

    PRINCIPAL INVESTIGATOR

  • Volker Seifert, M.D.

    Goethe University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

October 1, 2007

Primary Completion

July 1, 2010

Study Completion

January 1, 2011

Last Updated

November 28, 2012

Results First Posted

November 28, 2012

Record last verified: 2012-10

Locations

DE(1)