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| Sponsored by: |
National Taiwan University Hospital |
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00243490 |
Purpose
Primary Objective:
Secondary Objective:
| Condition | Intervention | Phase |
|
Malignant Intracranial Tumors Glioblastoma Multiforme Anaplastic Astrocytomas Anaplastic Oligodendrogliomas Anaplastic Ependymoma |
Procedure: Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M |
Phase II |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 5 |
| Estimated Study Completion Date: | January 2009 |
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 Steroids are withdrawn 2-3 days prior to sensitization.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.
Eligibility
| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jui-Chang Tsai, M.D. Ph.D. | 886-2-23123456 ext 5422 | jctsai@ha.mc.ntu.edu.tw |
| Taiwan | |||||
| National Taiwan University Hospital | |||||
| Taipei, Taiwan | |||||
| National Taiwan University Hospital |
| Principal Investigator: | Jui-Chang Tsai, M.D. Ph.D. | National Taiwan University College of Medicine |
More Information
| Study ID Numbers: | 33MD01 |
| First Received: | October 20, 2005 |
| Last Updated: | March 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00243490 |
| Health Authority: | Taiwan: Department of Health |
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