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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2026
  • participants needed
    106
  • sponsor
    University Hospital Muenster
Updated on 27 April 2021

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.

Details
Condition Glioblastoma Multiforme, Adult, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme, Adult
Treatment Stereotactic biopsy, Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid
Clinical Study IdentifierNCT04469699
SponsorUniversity Hospital Muenster
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Age 18 - 75 years
Karnofsky Performance Score (KPS) of 60 %
Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular and diencephalon. Tumors in the brain stem are excluded. First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Not necessarily identical to primary tumor location
Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm
For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study

Exclusion Criteria

Multifocal disease > 2 locations
Patients with significant non-enhancing tumor portions
Previous treatment of recurrence
Other malignant disease except basalioma
Hypersensitivity against porphyrins or Gliolan or Fluorethylenpropylen (FEP )
Porphyria
HIV infection, active Hepatitis B or C infection
Bone marrow reserve
white blood cell (WBC) count <2000/l
platelets <100000/l
Liver function
total bilirubin > 1.5 times above upper limit of normal range (ULN)
alanine transaminase (ALT) and aspartate transaminase (AST) > 3 times ULN
Renal function
creatinine > 1.5 times ULN
Blood clotting
Quick/INR or PTT out of acceptable limits
Conditions precluding MRI (e.g. pacemaker)
Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
Any active infection (at the discretion of the investigator)
Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator's opinion, compromises the patient's ability to understand the patient information, to give informed consent or to comply with the trial protocol
Previous antiangiogenic treatment
Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial
Pregnancy or breastfeeding
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