NCT06618300Active, not recruiting

Streamlined Resin Y90 Radiation Segmentectomy for Small HCC

Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One&Done Trial

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

This single-arm feasibility study evaluating the safety and efficacy of streamlining Yttrium-90 (Y90) radioembolization workflow for patients with small Hepatocellular Carcinoma (\<5cm) that have no aggressive features on baseline imaging. This study aims to recruit N=30 patients prospectively and consolidate the current workflow of 2 days of procedures (1st-day mapping angiography followed by nuclear medicine hepatic lung shunt fraction (LSF) calculation using Tc99-MAA planar and SPECT/CT, and 2nd-day Y90 radioembolization followed by nuclear medicine Y90 SPECT/CT) into 1-day procedure. Several studies have shown that hepatic LSF for HCC tumors smaller than 5cm in the absence of macrovascular invasion and portosystemic shunt placement is invariably \<10%. Therefore, the LSF calculation can be safely omitted from the complex workflow of these patients. This study aims to illustrate that this can be done safely and efficaciously to reduce unnecessary patient travel and healthcare resource utilization. Overall, a total of 30 patients will be included in the study.

Status (registry): Active, not recruiting
Study type: Observational
Enrollment: 30 (actual)
First submitted: 25 Sept 2024
Start date: 6 Nov 2024
Primary completion date: 31 Dec 2026
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Diseases: Liver and biliary tract cancer
NCT number: NCT06618300

What you commit to

Study type: Observational
Participants enrolled: 30
From 6 Nov 2024 to the primary completion date, 31 Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 48 hours prior to the treatment or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)

Other illness

Patients with chronic lung disease requiring supplemental oxygen at baseline or baseline SpO2 of \&lt;92%
Known hypersensitivity to iodinated contrast agents or to any component of iodinated contrast agents refractory to standard medications (antihistamines, steroids)

Lab values

Total bilirubin level \&gt; 3.0 mg/dL
Serum albumin level \&lt; 2.5 g/dL
Impaired kidney function (glomerular filtration rate \&lt; 30 as approximated using serum creatinine levels) unless anuric and on dialysis.

Other

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
The presence of trans-jugular intrahepatic portosystemic shunt
Aspartate and alanine aminotransferase levels no greater than five times the normal level
Life expectancy \&lt; 12 weeks
Eastern Cooperative Oncology Group performance status \&gt; 2
Patients that have tumors with central anatomical locations close the hepatic hilum or caudate lobe.
Patients with macrovascular invasion on baseline imaging

Who the study is looking for

18 years of age or older
Has focal Hepatocellular Carcinoma and is deemed to benefit from Yttrium-90 radioembolization by the institutional multidisciplinary tumor board

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
UNC Hospitals Coordinator of this site? Confirm its status	Chapel Hill	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.