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

Brain Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755142
• Other study ID #: MC-ALS.8-I/GLI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 22, 2016
• Last updated: May 20, 2016
• Start date: February 2000
• Est. completion date: June 2001

Study information

• Verified date: April 2016
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2001
• Est. primary completion date: June 2001
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms

Intervention

Biological:
• Gliolan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
medac GmbH	IKP

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	Within 3 hours	No