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

NCT01016002 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-11-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biolitec Pharma Ltd.

    collaborator INDUSTRY

  • University of Salzburg

    lead OTHER

Principal Investigators

  • Frieder Berr, Prof., MD · Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria

  • Lohse A, Prof., MD · University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2011-12-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016002 on ClinicalTrials.gov