Clinical Trial: Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Brief Summary:
Primary Objective:
- The primary objective is to evaluate the efficacy of photodynamic therapy in the treatment of malignant intracranial tumors.
Secondary Objective:
- The secondary objective is to evaluate the safety of photodynamic therapy in the treatment of malignant intracranial tumors.
Detailed Summary: 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 Steroids are withdrawn 2-3 days prior to sensitization.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.
Sponsor: National Taiwan University Hospital
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Taiwan University Hospital
Dates:
Date Received: October 20, 2005
Date Started:
Date Completion: January 2009
Last Updated: January 11, 2010
Last Verified: January 2010
