Trials / Withdrawn
WithdrawnNCT00243490
Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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 description
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 Steroids are withdrawn 2-3 days prior to sensitization.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.
Conditions
- Malignant Intracranial Tumors
- Glioblastoma Multiforme
- Anaplastic Astrocytomas
- Anaplastic Oligodendrogliomas
- Anaplastic Ependymoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M |
Timeline
- Completion
- 2009-01-01
- First posted
- 2005-10-24
- Last updated
- 2010-01-12
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00243490. Inclusion in this directory is not an endorsement.