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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00010560
Enrollment
100
Registered
2017-08-29
Start date
2017-07-17
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic metastatic colorectal cancer C50 C22

Interventions

Group 1: The individual therapy regimen provides for a long-term treatment of liver metastases of local ablative methods (radiofrequency ablation, microwave ablation or HDR brachytherapy). All the exa

Sponsors

Klinik und Poliklinik für Radiologie Klinikum der Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: • contraindication for local ablation of liver • Extrahepatic tumor manifestations before local Ablation treatment • Life expectancy 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

Design outcomes

Primary

MeasureTime frame
Leukocyte infiltration in tumor tissue (Histo) release of growth factors and cytokines, determined by laboratory analysis of all parameters to be collected at the end of the recruitment phase.

Secondary

MeasureTime frame
Isolation of tumor cell lines from Bioptat

Countries

Germany

Contacts

Public ContactChristel Besseler

Klinik und Poliklinik für RadiologieKlinikum der Universität München

christel.besseler@ed.ovgu.de+49-89 4400-44460

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026