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

Sponsor

medac GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00241670

Collaborator

(none)

415

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer Brain Tumors Cancer of Brain Primary Brain Tumors Brain Tumor, Primary	Drug: 5-aminolevulinic acid (5-ALA)	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

415 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5-aminolevulinic acid	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
No Intervention: Conventional resection

Arm

Intervention/Treatment

Experimental: 5-aminolevulinic acid

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

No Intervention: Conventional resection

Outcome Measures

Primary Outcome Measures

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]
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]

Secondary Outcome Measures

1. Overall survival. [Until 18 months after surgery]
2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment [Until 18 months after surgery]
3. Volume of residual tumour [After surgery]
4. Toxicity after oral administration of 5-Aminolevulinic acid. [Until 18 month after surgery]
5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment [Until 18 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

medac GmbH

Investigators

Study Chair: Hans-Juergen Reulen, MD, Ludwig-Maximilians - University of Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

medac GmbH

ClinicalTrials.gov Identifier:

NCT00241670

Other Study ID Numbers:

MC-ALS.3/GLI

First Posted:

Oct 19, 2005

Last Update Posted:

Apr 26, 2012

Last Verified:

Apr 1, 2012

Additional relevant MeSH terms:

Glioma

Brain Neoplasms

Aminolevulinic Acid

Study Results

No Results Posted as of Apr 26, 2012