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


N/A
18 Years
N/A
Not Enrolling
Both
Primary Malignant Neoplasm of Nervous System, Glioma, Glioblastoma, Metastasis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Extent of Resection

Outcome Description:

The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.

Outcome Time Frame:

Early postoperative MRI within 72 hrs

Safety Issue:

No

Principal Investigator

Christian Senft, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital

Authority:

Germany: Ethics Commission

Study ID:

JohannWGUH_IMAGER

NCT ID:

NCT01798771

Start Date:

March 2013

Completion Date:

February 2016

Related Keywords:

  • Primary Malignant Neoplasm of Nervous System
  • Glioma
  • Glioblastoma
  • Metastasis
  • primary brain tumor
  • malignant glioma
  • intraoperative MRI
  • 5-ALA
  • Brain Neoplasms
  • Neoplasms
  • Glioblastoma
  • Glioma
  • Neoplasm Metastasis
  • Nervous System Neoplasms

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