RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study
ConditionLiver Cancer, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Presence of macrovascular invasion,
Presence of extrahepatic disease,
Cholangiocarcinoma or mixed HCC-cholangiocarcinoma
Not willing to attend follow-up visits.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 1 trial groupSponsors and collaborators
Ankara University
Lead sponsor
Sirtex Medical
Collaborator
Source ClinicalTrials.gov