Streamlined Resin Y90 Radiation Segmentectomy for Small HCC
One&Done
One&Done
Sponsor study identifier
observational
30
1 country
1
Study Start
November 6, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2024
Actual (reported)October 1, 2024
Actual (reported)November 6, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
3 days
Duration of response
12 months
The safety of streamlined Y90 radioembolization
1, 3, 6, and 12 months post Y90 radioembolization
Response to streamlined Y90
12 months
Hepatic lung shunt fraction
3 days
Patients with small Hepatocellular Carcinoma undergoing Yttrium-90 (Y90) radioembolization.
Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization
UNC Hospitals
Chapel Hill, North Carolina, 27599, United States
Hyeon Yu, MD, FSIR
UNC Department of Radiology
30 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2024
First Posted
October 1, 2024
Study Start
November 6, 2024
Actual (reported)Y90 Radiation Segmentectomy vs SBRT for HCC
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 13, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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