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

Medac

Status and phase

Completed

Phase 3

Conditions

Brain Tumors

Primary Brain Tumors

Brain Tumor, Primary

Cancer of Brain

Brain Cancer

Treatments

Drug: 5-aminolevulinic acid (5-ALA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241670

MC-ALS.3/GLI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

415 patients

Sex

All

Ages

18 to 72 years old

Volunteers

No Healthy Volunteers

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