Trial document





This trial has been registered retrospectively.
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  DRKS00004966

Trial Description

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Title

Clinical Phase II Trial of 5-Aminolevulinic Acid Hydrochloride (5-ALA, 5-ALS) for Fluorescence-Guided Resection of Malignant Glioma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

During surgery for malignant brain tumors it is often difficult for the surgeon to distinguish between tumor and normal brain tissue. It has been demonstrated that 5-ALA, the body's own substance, can make tumors fluoresce, that is, they glow red when illuminated with blue light. It is the aim of the present study to determine exactly whether fluorescence truly shows tumor or whether normal brain is stained as well. For this purpose small samples from fluorescing tissue will be collected during surgery and studied under the microscope.

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Brief Summary in Scientific Language

This study examines the postive predictive value of tissue fluorescence in malignant glioma tissue after patients are given 5-ALA at a dose of 20 mg/kg b.w. The intensitiy of fluorescence will be spectrometrically.

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Organizational Data

  •   DRKS00004966
  •   2013/05/10
  •   [---]*
  •   no
  •   Approved
  •   201/02, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C71.9 -  Malignant neoplasm: Brain, unspecified
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Interventions/Observational Groups

  •   Fluorescence-guided resections fo malignant gliomas after oral application of 5-ALA (5-aminolevulinic acid) at a dose of 20 mg/kg body weight
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

Determination of the positive predictive value of tissue fluorescence, defined as the fraction of patients in whom all biopsies taken from fluorescing tissue truly show tumor infiltration.

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Secondary Outcome

1. Determination of the positive predictive value of fluorescence based on biopsies
2. Correlation of visible fluorescence to spectrometrical fluorescence and histology
3. Determination of whether visible fluorescence simplifies resection
4. Correlation of residual fluorescing tissue left unresected with early post-operative magnetic resonance imaging
5. Determination of toxicity according to standardized toxicity criteria (NCI Common Toxicicty Criteria CTC, [Version 1.0, modifiziert nach German Phase I, II, III Study Groups, New Drug Development Group (AWO) and Study Group of Pharmacology in Oncology and Hematology (APOH) of the Association for Medical Oncology (AIO) of the German Cancer Society)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2002/10/29
  •   33
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Suspected malignant glioma (WHO grades III or IV) according to MRI criteria
KPS >60
no prior tumor specific therapies
planned surgery

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Exclusion Criteria

Porphyria or sensitivity to porphyrins
Renal or hepatic disease
Dementia or other cognitive disorders precluding informed consent

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Addresses

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    • medac, Gesellschaft für klinische Spezialpräparate mbH
    • Fehlandstr. 3
    • 22880  Wedel
    • Germany
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    •   04103-8006-1
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    • Neurochirurgische Klinik Universtitätkslinikum Münster
    • Mr.  Prof. Dr. med.  Walter  Stummer 
    • Albert-Schweitzer Campus Geb. A1
    • 48149  Münster
    • Germany
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    • Neurochirurgische Klinik Universtitätkslinikum Münster
    • Mr.  Prof. Dr. med.  Walter  Stummer 
    • Albert-Schweitzer Campus Geb. A1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • medac Gesellschaft für medizinische Spezialprodukte mBH
    • Theaterstr. 6
    • 22880  Wdel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2004/06/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.