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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241670
• Other study ID #: MC-ALS.3/GLI
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: April 25, 2012
• Start date: October 1999

Study information

• Verified date: April 2012
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Within 72 hours after surgery	No
Primary	2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).		Within 6 month after surgery	No
Secondary	1. Overall survival.		Until 18 months after surgery	No
Secondary	2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment		Until 18 months after surgery	No
Secondary	3. Volume of residual tumour		After surgery	No
Secondary	4. Toxicity after oral administration of 5-Aminolevulinic acid.		Until 18 month after surgery	Yes
Secondary	5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment		Until 18 month after surgery	No