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Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma

NCT04469699 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-11

No results posted yet for this study

Summary

In this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent glioblastoma.

Conditions

  • Glioblastoma Multiforme, Adult

Interventions

DRUG

Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid

5-ALA HCl orally (20 mg/kg bw) 3,5-4,5 hours prior to induction of anaesthesia for stereotactic biopsy followed by stereotactical photodynamic therapy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).

PROCEDURE

Stereotactic biopsy

Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • photonamic GmbH & Co. KG

    collaborator INDUSTRY

  • medac GmbH

    collaborator INDUSTRY

  • LifePhotonic GmbH

    collaborator UNKNOWN

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Walter Stummer, Univ.-Prof. Dr. med. · University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469699 on ClinicalTrials.gov