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

Sponsor
University of Zurich (Other)
Overall Status
Unknown status
CT.gov ID
NCT01208909
Collaborator
(none)
40
Enrollment
1
Location
28
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Dec 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • patients with Glioblastoma multiforme (GBM)

    • no other tumor types or metastases

    Exclusion criteria:

    • Allergy against 5-ALA or Porphyrin

    • Porphyria

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UniversitätsSpital Zürich Zurich Switzerland

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Study Director: René L Bernays, MD, UniversitaetsSpital Zuerich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01208909
    Other Study ID Numbers:
    • ZU-XYZ-002
    First Posted:
    Sep 24, 2010
    Last Update Posted:
    Oct 22, 2010
    Last Verified:
    Feb 1, 2010
    Additional relevant MeSH terms:
    Glioblastoma

    Study Results

    No Results Posted as of Oct 22, 2010