Recruiting
Phase 2

Liver Tumor Ablation

Sponsor:

Northwestern University

Code:

NCT07586046

Conditions

HCC - Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres

Study Details

Brief summary:

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.

Conditions

HCC - Hepatocellular Carcinoma

Study ID

NCT07586046

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cirrhotic

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

active comparator: Non-cirrhotic

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.

Interventions

Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Andrew C Gordon, MD, PhD

(561)703-0134andrew.gordon@nm.org

Saad Abu Zahra, MD

646-996-2817saad.abuzahra@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Andrew C Gordon, MD, PhD

(561)703-0134andrew.gordon@nm.org

Saad Abu Zahra, MD

646-996-2817saad.abuzahra@northwestern.edu

Principal Investigator:

Andrew C Gordon, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Sep 15, 2026

Last verified

May, 2026

Keywords

  • MARGIN
  • HCC
  • Y90
  • Liver Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-09-15.