Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
University of Zurich

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA
tumor samples for pathophysiology

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: René L. Bernays, MD +41 (0)44 255 11 11

Locations
Layout table for location information
Switzerland
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: René L Bernays, MD    +41 44 25 ext 5111      
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Study Director: René L Bernays, MD UniversitaetsSpital Zuerich
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. R. L. Bernays, University of Zurich
ClinicalTrials.gov 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:
Layout table for 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