Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

Glioblastoma Clinical Trial

— IMAGER  

Official title:

Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01798771
• Other study ID #: JohannWGUH_IMAGER
• Secondary ID: 206/12
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2013
• Last updated: February 25, 2013
• Start date: March 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2013
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Christian Senft, MD PhD
• Phone: 069-6301
• Email: c.senft[@]med.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient (> 18 years) able to give informed consent

• primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma

• tumor must be deemed completely resectable by neurosurgeon

• diagnostic MRI

Exclusion Criteria:

• patient unable or unwilling to give informed consent

• infratentorial tumor location

• tumor location in or near eloquent areas

• multifocal tumor

• existance of contraindications to undergo MRI examination

• previous surgical treatment for an intraaxial brain tumor

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioblastoma
• Glioma
• Metastasis
• Neoplasms
• Nervous System Neoplasms
• Primary Malignant Neoplasm of Nervous System

Intervention

Procedure:
• Interventional arm
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
• Control arm
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

Locations

Country	Name	City	State
Germany	Klinik für Neurochirurgie Johann Wolfgang Goethe University	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIHSS	The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure	5 days following surgery	Yes
Primary	Extent of Resection	The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.	Early postoperative MRI within 72 hrs	No
Secondary	Volumetric extent of resection	Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.	Early postoperative MRI within 72hrs	No
Secondary	PFS 6	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection	6 months following surgery	No
Secondary	PFS 12	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection	12 months following surgery	No
Secondary	Quality of life	Patient quality of life at 6 and 12 months following surgery is a secondary endpoint	6 months/12 months	No

External Links

•   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. Epub 2011 Aug 23.