Brain Cancer, Brain Tumor, Primary, Brain Tumors, Cancer of Brain, Primary Brain Tumors
Conditions
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.
Interventions
1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
Sponsors
medac GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 3. Volume of residual tumour | After surgery |
| 1. Overall survival. | Until 18 months 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 |
| 4. Toxicity after oral administration of 5-Aminolevulinic acid. | Until 18 month after surgery |
| 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment | Until 18 months after surgery |
Outcome results
None listed