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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

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.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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:
      • Adana, Turkey (Türkiye)
        • Recruiting
        • Acibadem Adana Hospital
        • Contact:
      • Adana, Turkey (Türkiye)
        • Not yet recruiting
        • Cukurova University
        • Contact:
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Hacettepe University
        • Contact:
      • Ankara, Turkey (Türkiye)
        • Not yet recruiting
        • Bilkent City Hospital
        • Contact:
      • Ankara, Turkey (Türkiye)
        • Not yet recruiting
        • Gulhane Education and Research Hospital
        • Contact:
      • Denizli, Turkey (Türkiye)
        • Not yet recruiting
        • Pamukkale University
        • Contact:
      • Diyarbakır, Turkey (Türkiye)
        • Not yet recruiting
        • Gazi Yasargil Education and Research Hospital
        • Contact:
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Marmara University
        • Contact:
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Cam ve Sakura Education and Reseach Hospital
        • Contact:
      • Istanbul, Turkey (Türkiye)
        • Not yet recruiting
        • Istanbul Unicersity Cerrahpasa Medical School
        • Contact:
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul University Capa Medical School
        • Contact:
      • Izmir, Turkey (Türkiye)
        • Not yet recruiting
        • Acibadem Izmir Hospital
        • Contact:
      • Izmir, Turkey (Türkiye)
        • Not yet recruiting
        • Ege university
        • Contact:
      • Izmir, Turkey (Türkiye)
        • Recruiting
        • Katip Celebi Education and Research Hospital
        • Contact:
      • Kayseri, Turkey (Türkiye)
        • Recruiting
        • Erciyes University
        • Contact:
      • Kocaeli, Turkey (Türkiye)
        • Not yet recruiting
        • Kocaeli University
        • Contact:
      • Konya, Turkey (Türkiye)
        • Recruiting
        • Konya Selcuk University
        • Contact:
      • Malatya, Turkey (Türkiye)
        • Recruiting
        • Inonu University
        • Contact:
      • Mersin, Turkey (Türkiye)
        • Not yet recruiting
        • Mersin City Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Radiation Segmentectomy Group
Patients who will receive radioembolization for radiation segmentectomy intent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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