NCT07345247

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Aug 2028

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

December 28, 2025

Last Update Submit

January 20, 2026

Conditions

Liver Cancer, Adult

Keywords

Liver CancerRadioembolization

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of radiation segmentectomy

    Evaluation of response with modified RECIST criteria

    3 months after treatment

Secondary Outcomes (1)

  • Safety of radioembolization in radiation segmentectomy intent

    3 months after treatment

Study Arms (1)

Radiation Segmentectomy Group

Patients who will receive radioembolization for radiation segmentectomy intent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Acibadem Adana Hospital

Adana, Turkey (Türkiye)

RECRUITING

Adana City Hospital

Adana, Turkey (Türkiye)

NOT YET RECRUITING

Cukurova University

Adana, Turkey (Türkiye)

NOT YET RECRUITING

Bilkent City Hospital

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

Gulhane Education and Research Hospital

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Pamukkale University

Denizli, Turkey (Türkiye)

NOT YET RECRUITING

Gazi Yasargil Education and Research Hospital

Diyarbakır, Turkey (Türkiye)

NOT YET RECRUITING

Cam ve Sakura Education and Reseach Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul Unicersity Cerrahpasa Medical School

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Istanbul University Capa Medical School

Istanbul, Turkey (Türkiye)

RECRUITING

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

Acibadem Izmir Hospital

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

Ege University

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

Katip Celebi Education and Research Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Erciyes University

Kayseri, Turkey (Türkiye)

RECRUITING

Kocaeli University

Kocaeli, Turkey (Türkiye)

NOT YET RECRUITING

Konya Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

Inonu University

Malatya, Turkey (Türkiye)

RECRUITING

Mersin City Hospital

Mersin, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 15, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

TU(20)