Clinical Phase II Trial of 5-Aminolevulinic Acid Hydrochloride (5-ALA, 5-ALS) for Fluorescence-Guided Resection of Malignant Glioma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004966

Enrollment

Registered

2013-05-10

Start date

2002-10-29

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C71.9

Interventions

Group 1: Fluorescence-guided resections fo malignant gliomas after oral application of 5-ALA (5-aminolevulinic acid) at a dose of 20 mg/kg body weight

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Suspected malignant glioma (WHO grades III or IV) according to MRI criteria KPS >60 no prior tumor specific therapies planned surgery

Exclusion criteria

Exclusion criteria: Porphyria or sensitivity to porphyrins Renal or hepatic disease Dementia or other cognitive disorders precluding informed consent

Design outcomes

Primary

Measure	Time frame
Determination of the positive predictive value of tissue fluorescence, defined as the fraction of patients in whom all biopsies taken from fluorescing tissue truly show tumor infiltration.	—

Secondary

Measure	Time frame
1. Determination of the positive predictive value of fluorescence based on biopsies 2. Correlation of visible fluorescence to spectrometrical fluorescence and histology 3. Determination of whether visible fluorescence simplifies resection 4. Correlation of residual fluorescing tissue left unresected with early post-operative magnetic resonance imaging 5. Determination of toxicity according to standardized toxicity criteria (NCI Common Toxicicty Criteria CTC, [Version 1.0, modifiziert nach German Phase I, II, III Study Groups, New Drug Development Group (AWO) and Study Group of Pharmacology in Oncology and Hematology (APOH) of the Association for Medical Oncology (AIO) of the German Cancer Society)	—

Measure

Time frame

1. Determination of the positive predictive value of fluorescence based on biopsies 2. Correlation of visible fluorescence to spectrometrical fluorescence and histology 3. Determination of whether visible fluorescence simplifies resection 4. Correlation of residual fluorescing tissue left unresected with early post-operative magnetic resonance imaging 5. Determination of toxicity according to standardized toxicity criteria (NCI Common Toxicicty Criteria CTC, [Version 1.0, modifiziert nach German Phase I, II, III Study Groups, New Drug Development Group (AWO) and Study Group of Pharmacology in Oncology and Hematology (APOH) of the Association for Medical Oncology (AIO) of the German Cancer Society)

—

Countries

Germany

Contacts

Public ContactWalter Stummer

Neurochirurgische Klinik Universtitätkslinikum Münster

walter.stummer@ukmuenster.de0251 8347472

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026