Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
After passing Photosan® allergic test, the patients will be injected intravenously with
Photosan® (2mg/kg) during 15~30 minutes, 48 hours prior to a standard craniotomy.
Precautions are taken not to expose the patient in the operating room to direct room or
operating light and to shield the skin of the flap during operation. Steroids are withdrawn
2-3 days prior to sensitization. After maximal resection, the surface of the tumor bed will
be calculated and the generated cavity kept with a balloon containing intralipid (0.1%) or
saline and/or artificial spinal fluid in it. A fiber with a spherical diffuser will be
centered in the cavity and the surface irradiated with red (625~635nm) Halogen light. The
dose of light irradiation depends on individual condition of the patient, usually with an
energy density of 100 J/cm2 at a power density of 500 mW/cm2 to 600 mW/cm2.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The addition of photodynamic therapy to standard brain tumor treatments will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant intracranial tumors.
Jui-Chang Tsai, M.D. Ph.D.
National Taiwan University College of Medicine
Taiwan: Department of Health