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

Phase 1

Completed

• Conditions: Brain Neoplasm
• Interventions: Biological: Gliolan

• Registration Number: NCT02755142
• Lead Sponsor: medac GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2001-06
• Study Completion: 2001-06
• Status Verified: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 1	Gliolan	0,2 mg/Kg
Dose level 2	Gliolan	2,0 mg/Kg
Dose level 3	Gliolan	20 mg/Kg

Primary Outcome Measures

Name	Time	Method
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).	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.