Tumor Electric Fields Treatment System for Glioblastoma

This is an interventional device feasibility trial for Glioblastoma focused on measuring glioblastoma, tumor electric fields treatment Read More

Inclusion Criteria:

• Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
• Age between 18 and 65 years, male or female;
• Previously completed radiotherapy and at least two cycles of chemotherapy;
• With imaging or pathological evidence of tumor recurrence;
• Karnofsky performance score (KPS) score ≥ 70 before intervention;
• With a life expectancy more than 3 months;
• Adopted effective contraceptive measures at child-bearing age;
• Provided written informed consent.

Exclusion Criteria:

• Patients unwilling to use the equipment ≥ 18h per day;
• With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
• With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
• Within 3 months from radiotherapy;
• Within 4 weeks from the last cycle of chemotherapy;
• Within 4 weeks from surgery for recurrence;
• Participated in other clinical trials.
• Pregnant;
• Epilepsy symptoms not effectively controlled;
• Blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F. Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;
• With severe infectious diseases, such as acute severe infection and HIV positive;
• Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
• Other circumstances considered inappropriate to participate in the research by the investigator.