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Defining the Ablative Dose for Y-90 TARE

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment30 people
  • Recruiting US sites1
  • SponsorNorthwestern University
  • RegistryNCT07586046

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Defining the Ablative Dose for Y-90 TARE: a one-minute explainerNCT075860461 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
  • Age ≥18 years.
  • 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.

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres (Other): The objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.

The study

Treatment groups

Non Randomized · Parallel · masking: None

Cirrhotic (Active Comparator)

Cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee

Non-cirrhotic (Active Comparator)

Non-cirrhotic patients will begin at a dose of 200 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • CT scans: Part of the study plan
  • MRI: Part of the study plan
  • PET scans: Part of the study plan

Goals

What the study measures

Main goals

  • Ablative Dose Threshold for Y90 Radiation Segmentectomy (From enrollment to the end of post-treatment Y90 12 month follow up visit)
  • Impact of Cirrhosis on Ablative Dose Requirements (From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit)

Other goals

  • Correlation of Y90 Dose with Imaging Biomarkers
  • Tumor Response and Time-to-Progression Assessment
  • Safety and Tolerability of Escalating Y90 Doses

Planned enrollment: 30 (estimated).

Where

Recruiting US sites

  • Northwestern University, Chicago, Illinois

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Background research

Papers linked by the registry

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 14, 2026. Public record; not medical advice.

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