Clinical trial NCT06618300: Streamlined Resin Y90 Radiation Segmentectomy for Small HCC
Official title: Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One&Done Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: radioembolization
Yttrium-90
workflow
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Sirtex, Wodburn, MA
First posted: 2024-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization

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 (\&lt;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 \&lt;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.


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 \&amp;gt; 3.0 mg/dL
* Serum albumin level \&amp;lt; 2.5 g/dL
* Aspartate and alanine aminotransferase levels no greater than five times the normal level
* Life expectancy \&amp;lt; 12 weeks
* Eastern Cooperative Oncology Group performance status \&amp;gt; 2
* Patients with chronic lung disease requiring supplemental oxygen at baseline or baseline SpO2 of \&amp;lt;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 \&amp;lt; 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)

Primary outcomes:
measure: The treatment timeline
timeFrame: 3 days
measure: Cumulative charges and reimbursement
timeFrame: 3 days
Secondary outcomes:
measure: Duration of response
timeFrame: 12 months
measure: The safety of streamlined Y90 radioembolization
timeFrame: 1, 3, 6, and 12 months post Y90 radioembolization
measure: Response to streamlined Y90
timeFrame: 12 months
measure: Hepatic lung shunt fraction
timeFrame: 3 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: UNC Department of Radiology
name: Hyeon Yu, MD, FSIR
role: PRINCIPAL_INVESTIGATOR
References: