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

NCT ID: NCT01208909

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-12-31

Brief Summary

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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

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

Conditions

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Glioblastoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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diagnostic 5-ALA and MRI for tumor resection

diagnostic 5-ALA and MRI for tumor resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Allergy against 5-ALA or Porphyrin
* Porphyria
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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University of Zurich

Principal Investigators

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René L Bernays, MD

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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René L. Bernays, MD

Role: CONTACT

+41 (0)44 255 11 11

Facility Contacts

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René L Bernays, MD

Role: primary

+41 44 25 ext. 5111

Other Identifiers

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ZU-XYZ-002

Identifier Type: -

Identifier Source: org_study_id