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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University of Zurich.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208909
First Posted: September 24, 2010
Last Update Posted: October 22, 2010
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.
Information provided by:
University of Zurich
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Biospecimen Retention:   Samples Without DNA
tumor samples for pathophysiology

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: diagnostic 5-ALA and MRI for tumor resection
    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
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01208909


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

Locations
Switzerland
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: René L Bernays, MD    +41 44 25 ext 5111      
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: René L Bernays, MD UniversitaetsSpital Zuerich
  More Information

Responsible Party: Dr. R. L. Bernays, University of Zurich
ClinicalTrials.gov Identifier: NCT01208909     History of Changes
Other Study ID Numbers: ZU-XYZ-002
First Submitted: April 13, 2010
First Posted: September 24, 2010
Last Update Posted: October 22, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents