NCT01016002

Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Salzburg · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

Conditions

• Non-curative Resectable Bile Duct Carcinoma

Interventions

Type	Name	Description
DRUG	Temoporfin	Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-12-01
• First posted: 2009-11-18
• Last updated: 2009-11-18

Locations

2 sites across 2 countries: Austria, Germany