Radiation Segmentectomy With Resin Microspheres (RASEREM) Study for Liver Cancer

What this Trial Is About

This research aims to evaluate the safety and effectiveness of radiation segmentectomy (RS) using resin microspheres in patients with hepatocellular carcinoma (HCC) or liver metastases. RS is a targeted treatment that delivers Y-90 microspheres directly to the liver segment containing tumors, with most existing data based on glass microspheres. This study addresses the need to understand dosing limits and effectiveness specifically for resin microspheres. The study involves patients receiving radioembolization with resin microspheres intended as radiation segmentectomy, focusing on tumors in one or up to two neighboring liver segments. Researchers will assess the dose limits needed to achieve complete radiological response. Dosimetry calculations will be performed using advanced imaging software, and treatment response will be evaluated by MRI at 3 and 6 months post-treatment using mRECIST criteria. Tumor marker changes and laboratory tests will also be monitored. Participants will undergo clinical and laboratory assessments at baseline, 2 weeks, 1 month, and 3 months after treatment, including blood tests to monitor liver function and safety. Adverse events will be recorded and classified using standard criteria. The study plans to include 150 patients and will analyze outcomes to determine optimal dosing and safety parameters for resin microspheres in radiation segmentectomy over approximately 3 months of follow-up.

RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study