Liver Cancer, AdultRASEREMNCT07345247
RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study
An observational study of Liver Cancer, Adult, run by Ankara University at 20 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult
- How many people
- 150 participants
- Where
- 20 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include the patients who will receive radioembolization for radiation segmentectomy intent for primary or secondary liver tumors
Who may be able to join
- 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
Who cannot join
- Presence of macrovascular invasion,
- Presence of extrahepatic disease,
- Cholangiocarcinoma or mixed HCC-cholangiocarcinoma
- Not willing to attend follow-up visits.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Turkey (Türkiye)20 sites, 20 recruiting
- Recruiting
Acibadem Adana Hospital
Adana
Tugsan Balli, Prof, +905326566405, tugsanballi@gmail.com
- Not yet recruiting
Adana City Hospital
Adana
Nazim Barıs Kanat, Prof, +905053108780, nbkanat@gmail.com
- Not yet recruiting
Cukurova University
Adana
Isa Burak Guney, Asc Prof, +905323777003, burak_g@yahoo.com
- Not yet recruiting
Bilkent City Hospital
Ankara
Elif Ozdemir, Prof, +905326841880, ozdemire80@gmail.com
- Not yet recruiting
Gulhane Education and Research Hospital
Ankara
Semra Ince, Prof, +905057104320, drsemra@gmail.com
- Recruiting
Hacettepe University
Ankara
Murat Fani Bozkurt, Prof, +905324924890, fanibozkurt@gmail.com
- Not yet recruiting
Pamukkale University
Denizli
Aziz Gultekin, Prof, +905054699348, agultekin@pau.edu.tr
- Not yet recruiting
Gazi Yasargil Education and Research Hospital
Diyarbakır
Halil Komek, Prof, +905064767778, halilkomek@gmail.com
- Recruiting
Cam ve Sakura Education and Reseach Hospital
Istanbul
Burcu Esen Akkas, Prof, +9055327450364, burcuesen@yahoo.com
- Not yet recruiting
Istanbul Unicersity Cerrahpasa Medical School
Istanbul
Onur Erdem Sahin, Asc Prof, +905557041806, onur.sahin@iuc.edu.tr
- Recruiting
Istanbul University Capa Medical School
Istanbul
Yasemin Sanlı, Prof, +905363213654, yasemin.sanli@yahoo.com
- Recruiting
Marmara University
Istanbul
Tunc Ones, Prof, +905333382453, tunc_ones@hotmail.com
- Not yet recruiting
Acibadem Izmir Hospital
Izmir
Emine Acar Akkaya, Asc Prof, +905354638081, emineacar@yahoo.com
- Not yet recruiting
Ege University
Izmir
Gamze Capa Kaya, Prof, +905325093869, gamzecapakaya@gmail.com
- Recruiting
Katip Celebi Education and Research Hospital
Izmir
Bulent Turgut, Prof, +905336593904, bulturgut@yahoo.com
- Recruiting
Erciyes University
Kayseri
Seyhan Karacavus, Prof, +905052678209, seyhan_k@gmail.com
- Not yet recruiting
Kocaeli University
Kocaeli
Hakan Demir, Prof, +905325471207, hakan_d@yahoo.com
- Recruiting
Konya Selcuk University
Konya
Hasan Onner, Prof, +905375401092, hasanonner@gmail.com
- Recruiting
Inonu University
Malatya
Ramazan Kutlu, Prof, +905322521475, ramazankutlu@gmail.com
- Not yet recruiting
Mersin City Hospital
Mersin
Berfin Temelli, Asc Prof, +905336632372, berfin_t@gmail.com
About this study
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 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.
- Conditions
- Liver Cancer, Adult
- Keywords
- Liver Cancer, Radioembolization
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Segmentectomy Group | Patients who will receive radioembolization for radiation segmentectomy intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of radiation segmentectomy
Evaluation of response with modified RECIST criteria
Measured: 3 months after treatment
Secondary outcomes (1)
Safety of radioembolization in radiation segmentectomy intent
Evaluation of toxicity of radiation segmentectomy at the 3 month of treatment with CTCAE grading
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345247
- Sponsor's protocol ID
- RASEREM
- Acronym
- RASEREM
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study
- ClinicalTrials.gov ID
- NCT07345247
- Acronym / sponsor ID
- RASEREM / RASEREM
- Conditions
- Liver Cancer, Adult
- Keywords
- Liver Cancer, Radioembolization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Segmentectomy Group | – | –Patients who will receive radioembolization for radiation segmentectomy intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include the patients who will receive radioembolization for radiation segmentectomy intent for primary or secondary liver tumors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of macrovascular invasion,
- Presence of extrahepatic disease,
- Cholangiocarcinoma or mixed HCC-cholangiocarcinoma
- Not willing to attend follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of radiation segmentectomy
Time frame: 3 months after treatment
Evaluation of response with modified RECIST criteria
1 secondary outcome
Safety of radioembolization in radiation segmentectomy intent
Time frame: 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, Adult, run by Ankara University at 20 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of radiation segmentectomy (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.