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Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

NCT00241670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2012-04-26

No results posted yet for this study

Summary

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Conditions

Interventions

DRUG

5-aminolevulinic acid (5-ALA)

1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Hans-Juergen Reulen, MD · Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00241670 on ClinicalTrials.gov