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Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection

Phase 3
18 Years
72 Years
Not Enrolling
Brain Cancer, Brain Tumors, Cancer of Brain, Primary Brain Tumors, Brain Tumor, Primary

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Trial Information

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a
combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally
considered beneficial but complete resection of contrast enhancing tumor is achieved in less
than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing
tumor intraoperatively.

Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in
malignant gliomas, a phenomenon under exploration for intraoperative identification and
resection of these tumors. This study investigated the benefit derived from
fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival
and morbidity.

Inclusion Criteria:

- Radiological suspicion of a unilocular malignant glioma with distinct ring- or
garland-shaped contrast agent-accumulating tumour structures and a core of reduced
intensity in the MRI (central necroses) with no significant non-staining tumour
tissue (exclusion of a secondary malignant glioma).

- Indication for surgical tumour resection. If radical resection is planned, the
location of the contrast agent-accumulating tumour should allow complete resection.

- First operation of the tumour, no other tumour-specific pretreatment

- Karnofsky at least 70 %

- Patient's written informed consent

- Age 18-72 years

Exclusion Criteria:

- Tumour location in the midline, basal ganglia, cerebellum or brain stem

- More than one contrast agent-accumulating lesion unrelated to the primary tumour or
extracerebral metastases

- Porphyria, hypersensitivity to porphyrins

- Renal insufficiency: Creatinine > 2.0 mg/dl

- Hepatic insufficiency: Bilirubin > 3 mg/dl

- Quick test < 60 %

- gamma-GT > 70 U/I

- Malignancies other than basaliomas

- Existing or planned pregnancy or lactation, or inadequate contraception

- Simultaneous participation in another clinical trial or participation in another
clinical trial in the 30 days preceding randomisation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).

Outcome Time Frame:

Within 72 hours after surgery

Safety Issue:


Principal Investigator

Hans-Juergen Reulen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ludwig-Maximilians - University of Munich


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Brain Cancer
  • Brain Tumors
  • Cancer of Brain
  • Primary Brain Tumors
  • Brain Tumor, Primary
  • Brain Neoplasms
  • Glioma