Streamlined Resin Y90 Radiation Segmentectomy for Small HCC

NCT06618300 | Enrolling By Invitation DMC

• 1 other identifier: LCCC2401
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

radioembolization; Yttrium-90; workflow

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

Yttrium-90 (Y90) radioembolization

Patients with small Hepatocellular Carcinoma undergoing Yttrium-90 (Y90) radioembolization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization

You may qualify if:

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

You may not qualify if:

• The presence of trans-jugular intrahepatic portosystemic shunt
• Total bilirubin level \> 3.0 mg/dL
• Serum albumin level \< 2.5 g/dL
• Aspartate and alanine aminotransferase levels no greater than five times the normal level
• Life expectancy \< 12 weeks
• Eastern Cooperative Oncology Group performance status \> 2
• Patients with chronic lung disease requiring supplemental oxygen at baseline or baseline SpO2 of \<92%
• Patients that have tumors with central anatomical locations close the hepatic hilum or caudate lobe.
• Patients with macrovascular invasion on baseline imaging
• Known hypersensitivity to iodinated contrast agents or to any component of iodinated contrast agents refractory to standard medications (antihistamines, steroids)
• Impaired kidney function (glomerular filtration rate \< 30 as approximated using serum creatinine levels) unless anuric and on dialysis.
• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Sirtex, Wodburn, MA: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hyeon Yu, MD, FSIR

  UNC Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)