Skip to main content
OpenTrials
Completed

NCT Number: NCT00241670

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Brain Tumor, Primary Brain Tumors Cancer of Brain Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Primary Brain Tumors

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-aminolevulinic acid (5-ALA)

Drug

1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

medac GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
First posted
Oct 19, 2005
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.