- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241670
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 5-aminolevulinic acid
|
1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
|
NO_INTERVENTION: Conventional resection
|
What is the study measuring?
Primary Outcome Measures
Outcome 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).
Time Frame: Within 72 hours after surgery
|
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).
Time Frame: Within 6 month after surgery
|
Within 6 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Overall survival.
Time Frame: Until 18 months after surgery
|
Until 18 months after surgery
|
2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
Time Frame: Until 18 months after surgery
|
Until 18 months after surgery
|
3. Volume of residual tumour
Time Frame: After surgery
|
After surgery
|
4. Toxicity after oral administration of 5-Aminolevulinic acid.
Time Frame: Until 18 month after surgery
|
Until 18 month after surgery
|
5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment
Time Frame: Until 18 month after surgery
|
Until 18 month after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hans-Juergen Reulen, MD, Ludwig-Maximilians - University of Munich
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Glioma
- Brain Neoplasms
- Photosensitizing Agents
- Dermatologic Agents
- Aminolevulinic Acid
Other Study ID Numbers
- MC-ALS.3/GLI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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