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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
medac GmbH
ClinicalTrials.gov Identifier:
NCT00241670
First received: October 18, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Brain Cancer
Brain Tumors
Cancer of Brain
Primary Brain Tumors
Brain Tumor, Primary
Drug: 5-aminolevulinic acid (5-ALA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection

Resource links provided by NLM:


Further study details as provided by medac GmbH:

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). [ Time Frame: Within 72 hours after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Overall survival. [ Time Frame: Until 18 months after surgery ] [ Designated as safety issue: No ]
  • 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment [ Time Frame: Until 18 months after surgery ] [ Designated as safety issue: No ]
  • 3. Volume of residual tumour [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • 4. Toxicity after oral administration of 5-Aminolevulinic acid. [ Time Frame: Until 18 month after surgery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 415
Study Start Date: October 1999
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241670

Sponsors and Collaborators
medac GmbH
Investigators
Study Chair: Hans-Juergen Reulen, MD Ludwig-Maximilians - University of Munich
  More Information

No publications provided by medac GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT00241670     History of Changes
Other Study ID Numbers: MC-ALS.3/GLI
Study First Received: October 18, 2005
Last Updated: April 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 14, 2014