Hepatocellular Carcinoma (HCC)One&DoneNCT06618300
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC
An observational study of Hepatocellular Carcinoma (HCC), run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization
Who may be able to join
- 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
Who cannot join
- 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 \&gt; 3.0 mg/dL
- Serum albumin level \&lt; 2.5 g/dL
- Aspartate and alanine aminotransferase levels no greater than five times the normal level
- Life expectancy \&lt; 12 weeks
Show all 13Show fewer
- Eastern Cooperative Oncology Group performance status \&gt; 2
- Patients with chronic lung disease requiring supplemental oxygen at baseline or baseline SpO2 of \&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 \&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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One&Done Trial
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
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 (Y90) radioembolization | Patients with small Hepatocellular Carcinoma undergoing Yttrium-90 (Y90) radioembolization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 days
Secondary outcomes (4)
Duration of response
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.
Measured: 12 months
The safety of streamlined 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
Measured: 1, 3, 6, and 12 months post Y90 radioembolization
Response to streamlined Y90
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.
Measured: 12 months
Hepatic lung shunt fraction
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).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start6 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex, Wodburn, MA
- Responsible party
- Sponsor
- Investigators
- Hyeon Yu, MD, FSIR, Principal investigator, UNC Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618300
- Sponsor's protocol ID
- LCCC2401
- Acronym
- One&Done
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One&Done Trial
- ClinicalTrials.gov ID
- NCT06618300
- Acronym / sponsor ID
- One&Done / LCCC2401
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- radioembolization, Yttrium-90, workflow
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Sirtex, Wodburn, MA
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 (Y90) radioembolization | – | –Patients with small Hepatocellular Carcinoma undergoing Yttrium-90 (Y90) radioembolization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with small Hepatocellular Carcinoma receive Yttrium-90 (Y90) radioembolization
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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 \&gt; 3.0 mg/dL
- Serum albumin level \&lt; 2.5 g/dL
- Aspartate and alanine aminotransferase levels no greater than five times the normal level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The treatment timeline
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.
Cumulative charges and reimbursement
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon Yu, MD, FSIR principal investigator
UNC Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment timeline (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.