UNC Hospitals
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT06618300
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 days
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
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: 12 months
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: 1, 3, 6, and 12 months post 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: 12 months
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: 3 days
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).
UNC Lineberger Comprehensive Cancer Center
Other
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One&Done Trial
Acronym: One&Done
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