Clinical trial · Interventional
Defining the Ablative Dose for Y-90 TARE
A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)
NCT07586046CI-TRIAL-00111620MARGINrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC - Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cirrhotic
- description
- 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
- interventionNames
- Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres
- type
- ACTIVE_COMPARATOR
- label
- Non-cirrhotic
- description
- 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.
- interventionNames
- Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (22)
- BACKGROUNDGordon AC, Gates VL, White SB, Harris KR, Procissi D, Zhang Z, Li W, Samaan D, Nicolai JR, Mouli SK, Sato KT, Ryu RK, Omary RA, Salem R, Lewandowski RJ, Larson AC. Correlation and Agreement of Yttrium-90 Positron Emission Tomography/Computed Tomography with Ex Vivo Radioembolization Microsphere Deposition in the Rabbit VX2 Liver Tumor Model. J Vasc Interv Radiol. 2021 Jan;32(1):23-32.e1. doi: 10.1016/j.jvir.2020.09.016. Epub 2020 Nov 12. PMID 33189539
- BACKGROUNDLuetkens JA, Klein S, Traber F, Schmeel FC, Sprinkart AM, Kuetting DLR, Block W, Uschner FE, Schierwagen R, Hittatiya K, Kristiansen G, Gieseke J, Schild HH, Trebicka J, Kukuk GM. Quantification of Liver Fibrosis at T1 and T2 Mapping with Extracellular Volume Fraction MRI: Preclinical Results. Radiology. 2018 Sep;288(3):748-754. doi: 10.1148/radiol.2018180051. Epub 2018 Jun 26. PMID 29944086
- BACKGROUNDSyed M, Shah J, Montazeri SA, Grajo JR, Geller B, Toskich B. Analysis of dynamic hepatobiliary contrast-enhanced MRI signal intensity after Yttrium-90 radioembolization with glass microspheres for the treatment of hepatocellular carcinoma. Abdom Radiol (NY). 2021 May;46(5):2182-2187. doi: 10.1007/s00261-020-02855-2. Epub 2020 Nov 20. PMID 33216180
- BACKGROUNDBorhani AA, Elsayes KM, Catania R, Kambadakone A, Furlan A, Kierans AS, Kamath A, Harmath C, Horvat N, Humar A, Kielar AZ. Imaging Evaluation of Living Liver Donor Candidates: Techniques, Protocols, and Anatomy. Radiographics. 2021 Oct;41(6):1572-1591. doi: 10.1148/rg.2021210012. PMID 34597229
- BACKGROUNDRiaz A, Miller FH, Kulik LM, Nikolaidis P, Yaghmai V, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Gupta R, Wang E, Baker T, Abecassis M, Benson AB 3rd, Nemcek AA Jr, Omary R, Salem R. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262. PMID 20233824
- BACKGROUNDRiaz A, Kulik L, Lewandowski RJ, Ryu RK, Giakoumis Spear G, Mulcahy MF, Abecassis M, Baker T, Gates V, Nayar R, Miller FH, Sato KT, Omary RA, Salem R. Radiologic-pathologic correlation of hepatocellular carcinoma treated with internal radiation using yttrium-90 microspheres. Hepatology. 2009 Apr;49(4):1185-93. doi: 10.1002/hep.22747.