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Defining the Ablative Dose for Y-90 TARE in Liver Cancer

This study is investigating Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres for liver tumors (Hepatocellular Carcinoma or HCC) that cannot be removed by surgery. Doctors want to find the best amount of radiation (ablative dose) needed to completely destroy parts of the liver with cancer, while keeping the rest of your liver healthy. They will also see if this dose is different for people with or without cirrhosis (scarring of the liver). Success for this study means finding the right dose that completely destroys the tumor area, which will be checked using special MRI scans. This study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is designed to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy.
What's involved
You would receive Yttrium-90 Radiation Segmentectomy. You would also have specialized imaging, including PET/CT or PET/MRI scans, before and after treatment to evaluate the radiation distribution and liver response.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment to assess the ablative dose threshold and the impact of cirrhosis on dose requirements.

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NCT07586046

Defining the Ablative Dose for Y-90 TARE

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Northwestern University
~30 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ablative Dose Threshold for Y90 Radiation Segmentectomy
Measured over From enrollment to the end of post-treatment Y90 12 month follow up visit
+1 more outcome measured

Conditions

HCC - Hepatocellular Carcinoma

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Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Andrew C Gordon, MD, PhD
[email protected]
(561)703-0134
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
Age ≥18 years.
Tumor size ≤5 cm requiring treatment of ≤2 Couinaud segments.
Child-Pugh class A or B liver function
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate organ and bone marrow function as defined below:
Leukocytes (WBC) ≥ 3,000/mcL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Hemoglobin ≥ 9 g/dL
Platelets ≥ 50,000/mcL
Total bilirubin ≤ 3.0 mg/dL
AST ≤ 100 U/L, ALT ≤ 120 U/L
Creatinine ≤ 2.0 mg/dL or estimated GFR ≥ 40 mL/min/1.73 m²
Ability to undergo imaging and laboratory evaluations required by the study.
Ability to understand and willingness to sign a written informed consent document.

Exclusion

Extrahepatic metastases.
Pregnant or breastfeeding individuals.
Tumors requiring treatment of more than two Couinaud segments.
Known hypersensitivity to gadolinium-based contrast agents.
Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
Coagulopathy or clinical instability precluding angiographic intervention.
Prisoners or individuals under legal custody.
Adults unable to consent.
Individuals under 18 years of age.

What this trial measures

  • Ablative Dose Threshold for Y90 Radiation SegmentectomyFrom enrollment to the end of post-treatment Y90 12 month follow up visit

    To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI

  • Impact of Cirrhosis on Ablative Dose RequirementsFrom enrollment to enrollment to post-treatment Y-90 12 month follow-up visit

    To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients