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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241670
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : April 26, 2012
Information provided by (Responsible Party):
medac GmbH

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 1999
Actual Primary Completion Date : July 2004

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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 1. Overall survival. [ Time Frame: Until 18 months after surgery ]
  2. 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment [ Time Frame: Until 18 months after surgery ]
  3. 3. Volume of residual tumour [ Time Frame: After surgery ]
  4. 4. Toxicity after oral administration of 5-Aminolevulinic acid. [ Time Frame: Until 18 month after surgery ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241670

Sponsors and Collaborators
medac GmbH
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Study Chair: Hans-Juergen Reulen, MD Ludwig-Maximilians - University of Munich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: medac GmbH Identifier: NCT00241670    
Other Study ID Numbers: MC-ALS.3/GLI
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents