Radiation segmentectomy with Y-90 resin microspheres for liver tumors
RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study
This will test whether injecting Y-90 resin microspheres into the tumor-bearing part of the liver is safe and can shrink tumors in adults with liver cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ankara University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 20 sites (Adana and 19 other locations) |
| Trial ID | NCT07345247 on ClinicalTrials.gov |
What this trial studies
This is a multicenter prospective observational registry of adults with hepatocellular carcinoma or liver metastases treated with selective Y-90 resin microsphere infusion to the tumor-bearing hepatic segment. Teams will record administered dose, liver function, imaging responses, and adverse events at scheduled follow-up visits to determine safety and to describe dose thresholds linked to complete radiologic response. The main analysis will relate segmental radiation dose to rates of complete response, local control, and treatment-related toxicity. Data from participating centers in Adana, Turkey will be pooled to produce practical dose recommendations for resin microsphere segmentectomy.
Who should consider this trial
Good fit: Adults (≥18) with HCC or liver metastases who have one to three tumors confined to the same or neighboring liver segments, tumor size under 8 cm, Child–Pugh score below B9, and who can attend follow-up visits are ideal candidates.
Not a fit: Patients with macrovascular invasion, disease outside the liver, cholangiocarcinoma or mixed HCC‑cholangiocarcinoma, or those unable/unwilling to attend follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could define safe and effective dose limits for Y-90 resin segmentectomy and help doctors use this treatment more confidently.
How similar studies have performed: Existing evidence using glass microspheres shows strong safety and efficacy for radiation segmentectomy and retrospective reports suggest resin microspheres can work at lower doses, but prospective multicenter data for resin devices are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Adana and 19 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.