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

NCT ID: NCT00241670

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31

Brief 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.

Detailed 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.

Conditions

Brain Cancer; Brain Tumors; Cancer of Brain; Primary Brain Tumors; Brain Tumor, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

5-aminolevulinic acid

Group Type: EXPERIMENTAL

5-aminolevulinic acid (5-ALA)

Intervention Type: DRUG

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

Conventional resection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

5-aminolevulinic acid (5-ALA)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

medac GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Juergen Reulen, MD

Role: STUDY_CHAIR

Ludwig-Maximilians - University of Munich

References

Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.

Reference Type: DERIVED

PMID: 16648043 (View on PubMed)

Other Identifiers

MC-ALS.3/GLI

Identifier Type: -

Identifier Source: org_study_id