An observational study in Hepatocellular Carcinoma (HCC), sponsored by UNC Lineberger Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization
Exclusion Criteria:
Patients with small Hepatocellular Carcinoma undergoing Yttrium-90 (Y90) radioembolization.
The treatment timeline
The treatment timeline will be measured in days from the date of the initial consultation of the patient in the interventional radiology clinic to the date of the Yttrium-90 (Y90) radioembolization procedure.
Time frame: 3 days
Cumulative charges and reimbursement
To observe cumulative charges and reimbursement for streamlined Yttrium-90 (Y90) radioembolization treatment, billing, and reimbursement information will be obtained through the billing department. The costs will be reported in US dollars.
Time frame: 3 days
Duration of response
Duration of response in the treated area and elsewhere in the liver will be recorded. The response will be categorized as objective response vs no response based on mRECIST criteria and the percentage of patients achieving clinical success will be recorded.
Time frame: 12 months
The safety of streamlined Y90 radioembolization
To demonstrate the safety of streamlined Y90 radioembolization segmental treatment for small Hepatocellular Carcinoma (HCC) by observing the incidence of radiation-induced pneumonitis and liver toxicity. Clinical and biochemical toxicity will be well documented using Common Terminology for Adverse Events Version 5, 6,7 a
Time frame: 1, 3, 6, and 12 months post Y90 radioembolization
Response to streamlined Y90
To evaluate the efficacy of streamlined Y90 TARE for small Hepatocellular Carcinoma (HCC) using modified Response Evaluation for Solid Tumors (m-RECIST) and duration of response in the treated area and elsewhere in the liver at 12 months post-Y90. Efficacy will be categorized as objective response vs no response based on mRECIST criteria and the percentage of patients achieving clinical success will be recorded.
Time frame: 12 months
Hepatic lung shunt fraction
Hepatic lung shunt fraction (LSF) will be calculated using post-Yttrium-90 (Y90) radioembolization single photon emission computed tomography (SPECT) fused with computed tomography (CT) (SPECT/CT).
Time frame: 3 days
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center