THIAMAT-Local Ablative Therapy of Hepatic Malignomas - Proximity to untreated tumor tissue

Recruiting

Conditions: Hepatic metastatic colorectal cancer
C50
C22
Malignant neoplasm of breast
Malignant neoplasm of liver and intrahepatic bile ducts

Registration Number: DRKS00010560

Lead Sponsor: Klinik und Poliklinik für Radiologie Klinikum der Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

• hepatocellular carcinoma or hepatic metastatic colorectal cancer or hepatic metastatic disease
• male or female,> 18 years
• Indication for local ablation (RFA, HDR brachytherapy, microwave therapy) in two or more sessions
• Approval of all study procedures participate
• Signed informed consent
• Chemotherapy paused for min. 2 weeks before the confinement
• cortisone paused for at least 2 weeks prior to confinement

Exclusion Criteria

• contraindication for local ablation of liver
• Extrahepatic tumor manifestations before local Ablation treatment
• Life expectancy <3 months
• hepatic tumor volume> 70%
• chronic infections (except HBV / HCV infections in HCC patients)
• pronounced ascites
• contraindications for MRI contrast agent (Gd-EOB-DTPA), X-ray contrast agents, MRI and CT
• Cirrhosis (in hepatocellular carcinoma allowed)
• status post papilla resection / DHC stent / biliary manipulation
• severe cardiovascular disease (NYHA III / IV)
• thrombotic or embolic events in the past 6 months (stroke / TIA)
• severe hemorrhages in the last 3 months
• second malignancy within the last 5 years
• immunosuppression (e.g. in status post transplantation) or HIV, in particular cortisone
• autoimmune disease or inflammatory bowel disease
• cortisone therapy duration

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eukocyte infiltration in tumor tissue (Histo)<br>release of growth factors and cytokines, <br>determined by laboratory analysis of all parameters to be collected at the end of the recruitment phase.

Secondary Outcome Measures