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Combined Approach to Resection of Glioblastoma (GBM) by 5-Aminolevulinic Acid (5-ALA) and Intraoperative Magnetic Resonance Imaging (MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208909
Recruitment Status : Unknown
Verified February 2010 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : September 24, 2010
Last Update Posted : October 22, 2010
Information provided by:
University of Zurich

Brief Summary:

In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually considered a a first step of effective therapy. Radical resection of the tumor is highly beneficial to the patient as measured in progression-free survival and overall survival. At the same time eloquent areas of the brain have to remain intact to preserve quality of life.

Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor tissue and thereby to improve precision of GBM-Resection.

We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases the number of sites where tumor tissue can be detected.

- Trial with surgical intervention

Condition or disease Intervention/treatment
Glioblastoma Procedure: diagnostic 5-ALA and MRI for tumor resection

Detailed Description:
Precision of GBM-Resection Intraoperative marking of tumor tissue Combination of 5-ALA fluorescence and intraoperative MRI

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI
Study Start Date : August 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Intervention Details:
  • Procedure: diagnostic 5-ALA and MRI for tumor resection
    diagnostic 5-ALA and MRI for tumor resection

Biospecimen Retention:   Samples Without DNA
tumor samples for pathophysiology

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Glioblastoma multiforme (GBM)

Inclusion criteria:

  • patients with Glioblastoma multiforme (GBM)
  • no other tumor types or metastases

Exclusion criteria:

  • Allergy against 5-ALA or Porphyrin
  • Porphyria
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208909

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Contact: René L. Bernays, MD +41 (0)44 255 11 11

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UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: René L Bernays, MD    +41 44 25 ext 5111      
Sponsors and Collaborators
University of Zurich
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Study Director: René L Bernays, MD UniversitaetsSpital Zuerich
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Responsible Party: Dr. R. L. Bernays, University of Zurich Identifier: NCT01208909    
Other Study ID Numbers: ZU-XYZ-002
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue