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

Medac

Status and phase

Completed

Phase 2

Phase 1

Conditions

Brain Neoplasm

Treatments

Biological: Gliolan

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02755142

MC-ALS.8-I/GLI

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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