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

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.

Study Overview

• Status: Unknown
• Conditions: Glioma; Glioblastoma; Primary Malignant Neoplasm of Nervous System; Metastasis
• Intervention / Treatment: Procedure: Control arm; Procedure: Interventional arm

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Senft, MD PhD; Phone Number: 5939 069-6301; Email: c.senft@med.uni-frankfurt.de

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60528
      • Klinik für Neurochirurgie Johann Wolfgang Goethe University
      • Contact: Christian Senft, MD PhD; Phone Number: 5939 069-6301; Email: c.senft@med.uni-frankfurt.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control arm; 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.	Procedure: Control arm; 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.; Other Names: 5-ALA; 5-Aminolevulinic acid hydrochloride
Other: Interventional arm; 5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.	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.; Other Names: 5-ALA; 5-Aminolevulinic acid hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Resection	The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.	Early postoperative MRI within 72 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PFS 6	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection	6 months following surgery
PFS 12	Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection	12 months following surgery
Quality of life	Patient quality of life at 6 and 12 months following surgery is a secondary endpoint	6 months/12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS	The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure	5 days following surgery

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: Christian Senft, MD PhD, Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 25, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: primary brain tumor; malignant glioma; intraoperative MRI; 5-ALA
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Neoplasms; Glioblastoma; Brain Neoplasms; Nervous System Neoplasms; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: JohannWGUH_IMAGER; 206/12 (Other Identifier: Ethics Committee Johann Wolfgang Goethe University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No