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Defining the Ablative Dose for Y-90 TARE

RecruitingPhase 2

A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

About the study

This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.

What is being tested

Sponsor: Northwestern University · Participants: 30 · Started: May 15, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07586046

Locations in the U.S.

IllinoisNorthwestern University, Chicago

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.