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NCT01208909 Clinical Trial

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

Glioblastoma Clinical Trial

Official title:
Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01208909
Other study ID # ZU-XYZ-002
Secondary ID
Status Recruiting
Phase N/A
First received April 13, 2010
Last updated October 21, 2010
Start date August 2009
Est. completion date December 2011

Study information
Verified date February 2010
Source University of Zurich
Contact René L. Bernays, MD
Phone +41 (0)44 255 11 11
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion criteria:

- patients with Glioblastoma multiforme (GBM)

- no other tumor types or metastases

Exclusion criteria:

- Allergy against 5-ALA or Porphyrin

- Porphyria

- Pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland UniversitätsSpital Zürich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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