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Status unknownNCT01016002Updated Nov 18, 2009

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

A Phase 2 interventional study of Temoporfin in Non-curative Resectable Bile Duct Carcinoma, sponsored by University of Salzburg. Status unknown at 2 sites in 2 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-11-18.

Sponsored by University of Salzburg · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

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.

02

Conditions studied

  • Non-curative Resectable Bile Duct Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 35 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University of Salzburg is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:

    1. Bismuth type III or IV ( not resectable with R0-margins )
    2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
  • sufficient general condition to undergo PDT (Karnofsky status > 30%)
  • age > 19 years
  • access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
  • informed written consent

Exclusion criteria

Exclusion Criteria:

  • porphyria or other diseases exacerbated by light
  • known intolerance or allergies to porphyrin derivatives
  • a planned surgical procedure within the next 30 days
  • coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
  • impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
  • leukopenia ( WBC \< 2000/cmm ) or thrombopenia ( \< 50000/cmm ),
  • cytotoxic chemotherapy within the past 4 weeks.
  • pregnancy ( and safe contraception for 6 months after PDT )
  • accompanying/complicating disease with very poor prognosis (expected survival \< 6 weeks),
  • proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Intervention

    Drug: Temoporfin

Interventions

  • DrugTemoporfin

    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

    Also known as: Foscan, Meso-tetrahydroxyphenyl Chlorin

06

What researchers measure

Primary outcomes

  1. Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT

    Time frame: post treatment

Secondary outcomes

  1. Progression-free survival time, overall survival time

    Time frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

  2. Toxicity using WHO criteria and criteria for local toxicity in the biliary system

    Time frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

07

Study locations

2 of 2 sites recruiting
  • Department of Internal Medicine I, Paracelsus Medical University Salzburg
    Salzburg, 5020, Austria
    • Frieder Berr, Prof., MD · Contact · f.berr@salk.at
    • Frieder Berr, Prof., MD · Principal investigator
    Recruiting
  • Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
    Hamburg, 20246, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01016002
Lead sponsor
University of Salzburg
Collaborators
Biolitec Pharma Ltd.
First posted
Nov 18, 2009
Start date
Jan 2006
Primary completion
Dec 2011 (estimated)
Last update
Nov 18, 2009

Study contacts

Frieder Berr, Prof., MD
Contact
f.berr@salk.at
(43-) 662-4482 ext. 2800
Lohse A, Prof., MD
Contact
alohse@uke-uni-hamburg.de
+49-(0)40-4280 ext. 33 910
Frieder Berr, Prof., MD
principal investigator · Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Lohse A, Prof., MD
principal investigator · University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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