C22.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: histologically confirmed cholangiocellular carcinoma intrahepatic localization of a massforming CCC whole tumor bound of the liver not > 50% at least 1 lesion is accessible to an interventional therapy consent and ability to all study specific actions voluntary, informed and personally written consent Patient Age not under 18 and not over 85 years suitable cardiac, renal and haematological parameters
Exclusion criteria
Exclusion criteria: pregnant or breast-feeding women respectively possible pregnancy uncontrolled ascites other tumor diseases within the last 5 years (expect carcinoma in situ of the skin or zervix) uncooperative/noncompliant already participant of this study participation on another therapy study contraindication for Primovist-MRI or contrast-CT moderate or graved renal failure (GFR < 60 ml/min) appropriate to laboratory values 1 week before Primovist-MRI previous Radiation of the liver to clinic or investigator related patients acute or risk of acute severe bleeding (WHO grade 3-4) upper gastrointestinal bleeding in the last 3 month thrombembolic events including TIA in the last 6 month uncontrolled hypertonus life expactancy under 16 weeks state by orgn transplantation congenital immune defects immunsuppressive therapie in case of autoimmune disease or chronic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (follow-up time is planed until death of the patient or one year after the inclusion of the last study-patient) | — |
Secondary
| Measure | Time frame |
|---|---|
| time to uncontrolled local Progression, Overall survival, Quality of life (EQ-5D) (to be completed at time of inclusion, at brachytherapy and at follow up visits every 3 months) | — |
Countries
Germany
Contacts
Klinik für Radiologie und Nuklearmedizin