Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

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Key information

Conditions

Brain Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

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

Inclusion criteria

Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
Indication for surgical tumour resection
First operation of the tumour, no other tumour-specific pre-treatment
Karnofsky Performance Scale 70%
Patient's written informed consent
Age 18-75 years

Exclusion criteria

Porphyria, hypersensitivity to porphyrins
Renal insufficiency:

Creatinine > 2.0 mg/dl
Hepatic insufficiency:

Bilirubin > 3 mg/dl
Quick test < 60 %
GT > 100 U/I
Other known malignancy (except basaliomas)

Women:

Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)

Men:

Inadequate contraception (condom)
Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
Simultaneous participation or participation in another clinical trial in the preceding 30 days

Treatment and study plan

Gliolan

Biological

Other names: 5-Aminolevulinic Acid Hydrochloride (5-ALA)

Primary outcomes

Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).

Time frame: Within 3 hours

After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.

Sponsors and collaborators

Lead sponsor

medac GmbH

Industry

Collaborators

Registry information

Official study title

Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

Important dates

Study start: 2000
Primary completion: 2001
Study completion: 2001
First posted: Apr 28, 2016
Registry last updated: May 23, 2016

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.

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

Completed