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

Tracking Information
First Submitted Date April 13, 2010
First Posted Date September 24, 2010
Last Update Posted Date October 22, 2010
Study Start Date August 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Combined Approach to Resection of Glioblastoma (GBM) by 5-Aminolevulinic Acid (5-ALA) and Intraoperative Magnetic Resonance Imaging (MRI)
Official Title Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI
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

Detailed Description Precision of GBM-Resection Intraoperative marking of tumor tissue Combination of 5-ALA fluorescence and intraoperative MRI
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
tumor samples for pathophysiology
Sampling Method Non-Probability Sample
Study Population patients with Glioblastoma multiforme (GBM)
Condition Glioblastoma
Intervention Procedure: diagnostic 5-ALA and MRI for tumor resection
diagnostic 5-ALA and MRI for tumor resection
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September¬†23,¬†2010)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

  • Allergy against 5-ALA or Porphyrin
  • Porphyria
  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01208909
Other Study ID Numbers ZU-XYZ-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. R. L. Bernays, University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Study Director: René L Bernays, MD UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date February 2010