RECRUITING Phase 2 ClinicalTrials.gov

Defining the Ablative Dose for Y-90 TARE

Sponsor: Northwestern University • ClinicalTrials.gov ID: NCT07586046

Registry updated: 2026-09-15

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Description

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.

Interventions

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.

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.

Conditions

HCC - Hepatocellular Carcinoma

Locations

Northwestern University — Chicago, Illinois, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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