Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
NCT ID: NCT01016002
Last Updated: 2009-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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)
19 Years
ALL
No
Sponsors
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Biolitec Pharma Ltd.
INDUSTRY
University of Salzburg
OTHER
Responsible Party
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Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Principal Investigators
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Frieder Berr, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Lohse A, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
Locations
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Department of Internal Medicine I, Paracelsus Medical University Salzburg
Salzburg, Salzburg, Austria
Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
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Central Contacts
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Facility Contacts
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Frieder Berr, Prof., MD
Role: primary
A. Lohse, Prof., MD
Role: primary
Other Identifiers
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EUDRA CT 2005-004866-17
Identifier Type: -
Identifier Source: secondary_id
Foscan 1/2005
Identifier Type: -
Identifier Source: org_study_id