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Spots Global Cancer Trial Database for Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

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Trial Identification

Brief Title: Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

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

Study ID: NCT00243490

Study Description

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 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 Steroids are withdrawn 2-3 days prior to sensitization.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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Taiwan University Hospital, Taipei, , Taiwan

Contact Details

Name: Jui-Chang Tsai, M.D. Ph.D.

Affiliation: National Taiwan University College of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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