Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma.
NCT05451862 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-08-26
Summary
166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Further clinical evidence is needed to evaluate the safety and efficacy of 166Ho-TARE in the treatment of HCC patients with limited tumor burden, well preserved liver function and performance status and ineligible for liver transplantation and/or liver resection. This study will also provide further evidence on the dose-response relationship of 166Ho-TARE in (early) HCC.
Conditions
Interventions
- DEVICE
-
Holmium-166 treatment
Implantation into hepatic tumors by delivery via the hepatic artery for the treatment of unresectable HCC liver tumors.
- DEVICE
-
Holmium-166 work-up
Evaluation of lung-shunt, extrahepatic deposition and intrahepatic distribution of intra-arterially injected microspheres for patients that are eligible for TARE treatment.
Sponsors & Collaborators
-
Terumo Europe N.V.
lead INDUSTRY
Principal Investigators
-
Jens Ricke, Prof. Dr. med · Ludwig-Maximilian-University Munich (LMU)
-
Wolfgang Weber, Prof. Dr. med · Munich Technische Universität (TUM)
-
Thomas Kröncke, Prof. Dr. med · Universitätsklinikum Augsburg
-
Ralph Kickuth, Prof. Dr. med · Wuerzburg University Hospital
-
Karin Menhart, Dr. · Universitätsklinikum Regensburg
-
Peter Dietrich, PD. Dr. med. · Uniklinikum Erlangen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-21
- Primary Completion
- 2025-05-27
- Completion
- 2025-05-27
Countries
- Germany
Study Locations
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