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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394692
• Other study ID #: JWG-EK 239/07
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: October 29, 2012
• Start date: October 2007
• Est. completion date: January 2011

Study information

• Verified date: October 2012
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• intraoperative MRI-guided tumor resection
tumor resection with the use of an intraoperative MRI
• standard microsurgery
microsurgical tumor resection

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, Goethe-University	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-free Survival	Progression-free survival (radiological and/or clinical progression) at 6 months following surgery	6 months	No
Secondary	Volumetric Assessment	Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI	72 hours	No
Secondary	Neurological Deficit	Assessment of new postoperative deficits following tumor surgery	7 days	Yes