Ablative Dose Testing for Y-90 Radiation Segmentectomy in Liver Cancer
Official title: A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)
Run by Northwestern University · NCT07586046 · Data updated 2026-11-12
This study tests the best Y-90 radiation dose to fully ablate liver tumors in adults who can’t be removed or treated with standard methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | February 2029 |
| Study ends | May 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07586046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with HCC or liver-dominant disease not eligible for surgical resection or standard ablation, with adequate liver and marrow function and no extrahepatic metastases.
✕Probably not a fit
Patients with extensive liver disease, significant liver impairment, or extrahepatic metastases may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 study aims to define the optimal ablative dose for Y-90 radiation segmentectomy in patients with hepatocellular carcinoma or liver-dominant disease. Researchers will use pre- and post-treatment PET/CT or PET/MRI imaging to map how the radioactive beads distribute and how the liver responds over time. The imaging is standard, not experimental, and helps correlate dose delivery with tumor control and liver safety. Participants receive Yttrium-90–loaded glass microspheres targeted to the tumor-bearing liver segments. The trial includes adults with Child-Pugh A/B liver function and adequate organ reserves, without extrahepatic metastases.
Why it matters
Potential benefit: If successful, the study could establish a dosing range that maximizes tumor destruction while preserving healthy liver tissue.
How similar studies have gone: Prior Y-90–based approaches show promise in targeted liver therapy, but this study seeks to personalize the ablative dose, which is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Northwestern University
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Andrew C Gordon, MD, PhD
- Email: andrew.gordon@nm.org
- Phone: (561)703-0134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.