7 JCI-accredited hospitals 17 hospitals with oncology 65 oncology specialists 19 clinical trials recruiting
Oncology & Cancer Care
RecruitingObservationalNCT07345247

RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study

Radiation segmentectomy delivers tiny radioactive beads (Y-90 resin microspheres) directly into the part of the liver that holds a tumor. This observational study records how well this works and what dose is safe when resin beads are used.

SponsorAnkara University
Study typeObservational
Started2025-08-01
Primary completion2028-03-01
Planned enrolment150
Sites2 Acıbadem · 18 other

RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study

What this study is about

Radiation segmentectomy (RS) refers to selective infusion of Y-90 microspheres to the tumor bearing hepatic segment of hepatic artery. Majority of the data on RS is based on the Glass microspheres experience. Due to different properties of Resin and Glass microspheres description of dose limits to the segment for effectiveness of treatments with Resin microspheres are needed.

Based on this background in this study it is aimed to evaluate the safety and efficacy of RS with resin microspheres in HCC patients. Secondly, it is planned to describe the dose limits for complete radiological response.

+Read the detailed description

Radiation segmentectomy (RS) refers to selective infusion of Y-90 microspheres to the tumor bearing hepatic segment of hepatic artery. It was first described in 2011 and has been demonstrated to be a safe and reliable therapy able to deliver a curative intent high dose of selective ablative radiation for the treatment of hepatocellular carcinoma (HCC). This approach is gained to the radioembolization to a notable position in today's established algorithm for the multidisciplinary management of HCCs. Majority of the data on RS is based on the Glass microspheres experience. Due to different properties of Resin and Glass microspheres description of dose limits to the segment for effectiveness of treatments with Resin microspheres are needed.

In a recent retrospective study it is demonstrated that RS with resin microspheres are safe and effective In comparison to glass microspheres evet with lower radiation doses to the tumor. Despite this data on the effectiveness and safety of RS with resin microspheres in the multidisciplinary meeting I noticed that nuclear medicine specialist and interventional radiologist form our country rely on the use glass microspheres in the RS setting. As a nuclear medicine specialist who perform RS with resin microspheres I need to show the success of resin microspheres in RS with a multicenter prospective study. I believe that this multicenter experience would change clinical practice in our country and the scientific data that we will have would...

Conditions
  • Liver Cancer, Adult
Interventions
    Primary outcome measures
    • Effectiveness of radiation segmentectomy — 3 months after treatment
    Who can take part
    SexAllAge18 Years to no upper limitHealthy volunteersNo
    Inclusion
    * Patients aged ≥18 years * Underwent RE as a RS intent (have single or \<3 tumors in same or neighboring 2 segments) for the treatment of HCC or metastatic tumor to liver. * Presence of extrahepatic disease * Tumor size less than 8 cm * Child Pugh Score \<B9
    Exclusion
    * Presence of macrovascular invasion, * Presence of extrahepatic disease, * Cholangiocarcinoma or mixed HCC-cholangiocarcinoma * Not willing to attend follow-up visits.

    Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

    Acıbadem study sites
    • Acıbadem Adana Hospital, AdanaRecruiting
    • Acıbadem Izmir Hospital, IzmirOpening soon

    Also running at 18 other sites in 1 countries.

    Source: ClinicalTrials.gov NCT07345247 · last updated 2026-01-22 · View registry record ↗