RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study (RASEREM)

January 20, 2026 updated by: Cigdem Soydal, Ankara University

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.

Study Overview

Status

Recruiting

Conditions

Liver Cancer, Adult

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 place the resin microspheres to its real place in the RS setting worldwide.

All post treatment Y-90 PET images will be used for dosimetric estimations. Single compartment dosimetry will be performed in the treating center. If the center do not have dosimetric software calculation will be performed by PI in the Ankara University by using Slicer 3D software and a dedicated module for liver dosimetry. Response to the treatment will be evaluated by MRI imaging with liver specific contrast agent after 3 and 6 months treatment. mRECIST criteria will be used for evaluation. Additionally, change in serum tumor markers levels will be evaluated. Standard clinical protocol included clinical and laboratory evaluation at baseline, two weeks, one month, and three months after treatment. Laboratory markers for analysis will be: serum albumin, total bilirubin, alkaline phosphatase (AP), gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), and alanine transaminase (ALT). All events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Preexisting toxicities will be excluded unless they exacerbated after treatment.

Totally 150 patients are planning to include the analysis. ROC analysis will be use for determination of optimal cutoffs for mean tumor and segment absorbed doses to predict response and complete response. Multivariate regression model will be used for analysis of multiple factors for response. Lineer regression model will be perform for whole liver absorbed dose and toxicity evaluation.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey (Türkiye)
- - Adana, Turkey (Türkiye)
    - Not yet recruiting
    - Adana City Hospital
    - Contact:
      
      Nazim Barıs Kanat, Prof
      
      Phone Number: +905053108780
      
      Email: nbkanat@gmail.com
  - Adana, Turkey (Türkiye)
    - Recruiting
    - Acibadem Adana Hospital
    - Contact:
      
      Tugsan Balli, Prof
      
      Phone Number: +905326566405
      
      Email: tugsanballi@gmail.com
  - Adana, Turkey (Türkiye)
    - Not yet recruiting
    - Cukurova University
    - Contact:
      
      Isa Burak Guney, Asc Prof
      
      Phone Number: +905323777003
      
      Email: burak_g@yahoo.com
  - Ankara, Turkey (Türkiye)
    - Recruiting
    - Hacettepe University
    - Contact:
      
      Murat Fani Bozkurt, Prof
      
      Phone Number: +905324924890
      
      Email: fanibozkurt@gmail.com
  - Ankara, Turkey (Türkiye)
    - Not yet recruiting
    - Bilkent City Hospital
    - Contact:
      
      Elif Ozdemir, Prof
      
      Phone Number: +905326841880
      
      Email: ozdemire80@gmail.com
  - Ankara, Turkey (Türkiye)
    - Not yet recruiting
    - Gulhane Education and Research Hospital
    - Contact:
      
      Semra Ince, Prof
      
      Phone Number: +905057104320
      
      Email: drsemra@gmail.com
  - Denizli, Turkey (Türkiye)
    - Not yet recruiting
    - Pamukkale University
    - Contact:
      
      Aziz Gultekin, Prof
      
      Phone Number: +905054699348
      
      Email: agultekin@pau.edu.tr
  - Diyarbakır, Turkey (Türkiye)
    - Not yet recruiting
    - Gazi Yasargil Education and Research Hospital
    - Contact:
      
      Halil Komek, Prof
      
      Phone Number: +905064767778
      
      Email: halilkomek@gmail.com
  - Istanbul, Turkey (Türkiye)
    - Recruiting
    - Marmara University
    - Contact:
      
      Tunc Ones, Prof
      
      Phone Number: +905333382453
      
      Email: tunc_ones@hotmail.com
  - Istanbul, Turkey (Türkiye)
    - Recruiting
    - Cam ve Sakura Education and Reseach Hospital
    - Contact:
      
      Burcu Esen Akkas, Prof
      
      Phone Number: +9055327450364
      
      Email: burcuesen@yahoo.com
  - Istanbul, Turkey (Türkiye)
    - Not yet recruiting
    - Istanbul Unicersity Cerrahpasa Medical School
    - Contact:
      
      Onur Erdem Sahin, Asc Prof
      
      Phone Number: +905557041806
      
      Email: onur.sahin@iuc.edu.tr
  - Istanbul, Turkey (Türkiye)
    - Recruiting
    - Istanbul University Capa Medical School
    - Contact:
      
      Yasemin Sanlı, Prof
      
      Phone Number: +905363213654
      
      Email: yasemin.sanli@yahoo.com
  - Izmir, Turkey (Türkiye)
    - Not yet recruiting
    - Acibadem Izmir Hospital
    - Contact:
      
      Emine Acar Akkaya, Asc Prof
      
      Phone Number: +905354638081
      
      Email: emineacar@yahoo.com
  - Izmir, Turkey (Türkiye)
    - Not yet recruiting
    - Ege university
    - Contact:
      
      Gamze Capa Kaya, Prof
      
      Phone Number: +905325093869
      
      Email: gamzecapakaya@gmail.com
  - Izmir, Turkey (Türkiye)
    - Recruiting
    - Katip Celebi Education and Research Hospital
    - Contact:
      
      Bulent Turgut, Prof
      
      Phone Number: +905336593904
      
      Email: bulturgut@yahoo.com
  - Kayseri, Turkey (Türkiye)
    - Recruiting
    - Erciyes University
    - Contact:
      
      Seyhan Karacavus, Prof
      
      Phone Number: +905052678209
      
      Email: seyhan_k@gmail.com
  - Kocaeli, Turkey (Türkiye)
    - Not yet recruiting
    - Kocaeli University
    - Contact:
      
      Hakan Demir, Prof
      
      Phone Number: +905325471207
      
      Email: hakan_d@yahoo.com
  - Konya, Turkey (Türkiye)
    - Recruiting
    - Konya Selcuk University
    - Contact:
      
      Hasan Onner, Prof
      
      Phone Number: +905375401092
      
      Email: hasanonner@gmail.com
  - Malatya, Turkey (Türkiye)
    - Recruiting
    - Inonu University
    - Contact:
      
      Ramazan Kutlu, Prof
      
      Phone Number: +905322521475
      
      Email: ramazankutlu@gmail.com
  - Mersin, Turkey (Türkiye)
    - Not yet recruiting
    - Mersin City Hospital
    - Contact:
      
      Berfin Temelli, Asc Prof
      
      Phone Number: +905336632372
      
      Email: berfin_t@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Study population will include the patients who will receive radioembolization for radiation segmentectomy intent for primary or secondary liver tumors

Description

Inclusion Criteria:

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 Criteria:

Presence of macrovascular invasion,
Presence of extrahepatic disease,
Cholangiocarcinoma or mixed HCC-cholangiocarcinoma
Not willing to attend follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Radiation Segmentectomy Group Patients who will receive radioembolization for radiation segmentectomy intent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of radiation segmentectomy Time Frame: 3 months after treatment	Evaluation of response with modified RECIST criteria	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of radioembolization in radiation segmentectomy intent Time Frame: 3 months after treatment	Evaluation of toxicity of radiation segmentectomy at the 3 month of treatment with CTCAE grading	3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Collaborators

Sirtex Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RASEREM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.