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Enrolling by invitation NCT06618300

Streamlined Resin Y90 Radiation Segmentectomy for Small HCC

— Observational Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • The treatment timeline [Time frame: 3 days]
  • Cumulative charges and reimbursement [Time frame: 3 days]
Secondary outcome measures (4)
  • Duration of response [Time frame: 12 months]
  • The safety of streamlined Y90 radioembolization [Time frame: 1, 3, 6, and 12 months post Y90 radioembolization]
  • Response to streamlined Y90 [Time frame: 12 months]
  • Hepatic lung shunt fraction [Time frame: 3 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UNC Hospitals — Chapel Hill

Identifiers

NCT: NCT06618300 · LCCC2401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗