TheraSphere (yttrium 90 microspheres) / Boston Scientific - LARVOL DELTA

EMERALD-Y90: A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: Jul 2026 ➔ May 2027

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Intra-arterial delivery of Yttrium-90 glass microspheres in recurrent glioblastoma (rGBM): early results from the FRONTIER trial (SNO 2026) - No abstract available

Brain Cancer • Glioblastoma • Solid Tumor

BEAT-UT7: Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Seoul National University Hospital | Trial completion date: Dec 2029 ➔ Dec 2030 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

MANDARIN (S6371) (clinicaltrials.gov) - P3 | N=92 | Completed | Sponsor: Boston Scientific Corporation | Active, not recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor

Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy. (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: University of Michigan Rogel Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatocellular Cancer • Oncology • Solid Tumor

Phase I Dose-Escalation Study Combining Irinotecan-Loaded Drug-Eluting Bead Chemoembolization with Yttrium-90 Glass Microspheres Radioembolization in Colorectal Liver Metastases (DEBIR90Y). (PubMed, J Vasc Interv Radiol) - "In this phase I study in patients with liver-dominant colorectal metastases, receiving a combination of yttrium-90 radioembolization with DEBIRI combined with DEBIRI, the maximum tolerated dose was 80 Gy. Considerable treatment-related toxicity was observed and objective response rates were limited."

Journal • P1 data • Hepatology • Liver Failure • Oncology • Pain • CEACAM5

Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: University of California, San Francisco | Trial completion date: Dec 2028 ➔ Mar 2029 | Initiation date: May 2026 ➔ Oct 2026 | Trial primary completion date: Dec 2028 ➔ Mar 2029

Trial completion date • Trial initiation date • Trial primary completion date • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

FRONTIER: A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Boston Scientific Corporation | Trial primary completion date: Jul 2026 ➔ Oct 2026

Trial primary completion date • Brain Cancer • Glioblastoma • Neutropenia • Oncology • Solid Tumor

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: University of Miami | N=30 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hepatocellular Cancer • Oncology • Solid Tumor

ADVANCE-MCD: A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. (clinicaltrials.gov) - P=N/A | N=140 | Not yet recruiting | Sponsor: Boston Scientific Corporation

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Yttrium-90 measurements with radionuclide calibrators: Comparison to Monte Carlo models and geometry effects. (PubMed, Appl Radiat Isot) - "Yttrium-90 glass microspheres are used in the treatment of liver cancer...Through a series of measurements and Monte Carlo simulations, we have tested that experimental model, finding it to be valid. New ionization chamber measurements provide links to earlier work."

Journal • Liver Cancer • Oncology • Solid Tumor

Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Jun 2027 ➔ Mar 2030 | Trial primary completion date: Jun 2026 ➔ Mar 2029

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Northwestern University | Suspended ➔ Recruiting | N=84 ➔ 200 | Trial completion date: Jul 2026 ➔ Jul 2040 | Trial primary completion date: Jul 2026 ➔ Jul 2040

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Correlation of Voxel-Based Dosimetric Parameters With Progression-Free Survival and Overall Survival After Yttrium-90 Glass Microsphere Radioembolisation in Hepatocellular Carcinoma (SNMMI 2026) - "This retrospective study aimed to focus on voxel-based dosimetry analysis imaging after RE. It particularly examines how the dose received by the tumour volume affects OS and PFS. Our findings indicate that the D50 threshold is a more significant prognostic factor than mean TAD and other DVH parameters, such as D70 and D90."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

188Re-microspheres for Selective Internal Radiation Therapy: A Promising and Affordable Approach for treatment of Hepatocellular Carcinoma (SNMMI 2026) - "Info Purpose/Background: Selective Internal Radiation Therapy (SIRT) using 90Y-Theraspheres is a well-established treatment for hepatocellular carcinoma (HCC)... Sixty patients with Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC were treated with 188Re-SIRT, receiving a mean administered activity of 3,678 ± 1,214 MBq (100 ± 33 mCi) of 188Re microspheres, in combination with sorafenib... This study establishes the preliminary efficacy of ¹⁸⁸Re-SIRT as a safe, well-tolerated, and cost-effective treatment for achieving local tumor control in HCC, with no significant adverse events. The integration of FDG PET/TPCT for response assessment emphasized the value of volumetric PET parameters in refining disease prognostication. The study findings support the broader clinical adoption of ¹⁸⁸Re-SIRT, particularly in resource-limited settings."

Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Liver Cancer • Oncology • Solid Tumor

Tumor absorbed dose and outcomes after Y-90 glass radioembolization for colorectal liver metastases: does dose escalation improve survival in real-world practice? (PubMed, Eur J Nucl Med Mol Imaging) - "In a real-world population of heavily pretreated patients with CRCLM, escalation of TAD beyond 189 Gy did not translate into improved survival, highlighting the dominant impact of advanced disease burden and extrahepatic progression."

Journal • Real-world evidence • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

SPLENIC-SIRT: A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer (clinicaltrials.gov) - P=N/A | N=18 | Not yet recruiting | Sponsor: Centre Georges Francois Leclerc

New trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Thrombocytopenia

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University of Miami | Trial completion date: May 2031 ➔ Aug 2031 | Trial primary completion date: May 2031 ➔ Aug 2031

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Effectiveness and safety of selective internal radiation therapy using yttrium-90 glass microspheres for hepatocellular carcinoma: real-world results from the multi-center prospective PROACTIF cohort of 989 patients. (PubMed, EClinicalMedicine) - P | "These findings support dosimetry-guided Y90 across all BCLC stages, and should inform future guideline recommendations. Boston Scientific Corporation."

Journal • Real-world evidence • Cardiovascular • Hematological Disorders • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Thrombosis

INDIGO: TheraSphere Japan Pre-Market Study (clinicaltrials.gov) - P=N/A | N=51 | Recruiting | Sponsor: Boston Scientific Corporation | Trial completion date: Apr 2027 ➔ Dec 2027 | Trial primary completion date: Mar 2027 ➔ Jun 2027

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University of Miami | Trial completion date: Jan 2031 ➔ May 2031 | Trial primary completion date: Jan 2031 ➔ May 2031

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

EMERALD-Y90: A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: Jan 2027 ➔ Jul 2026 | Trial primary completion date: Oct 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

PROACTIF: Final Results from the Largest, Prospective HCC Real World Study using Yttrium-90 (Y90) Glass (SIO 2026) - "Real world data with TheraSphere affirmed the safety and efficacy of Y90 in large HCC tumors, including patients with PVT, using tailored dosimetry across all BCLC stages. Median OS was particularly long for patients with subsequent surgery. When deciding HCC management, Y90 should be considered a treatment option, either alone, sequenced, or combined with other treatments, by multidisciplinary tumor boards."

Clinical • Real-world • Real-world evidence • Hepatocellular Cancer • Thrombosis

1st vs. 2nd Week - The Impact of Delivery Timing ofYttriumm-90 Microspheres for Hepatocellular Carcinoma (SIO 2026) - "Materials and A retrospective, single-institution study was performed on patients treated with yttrium-90 glass microspheres for solitary hepatocellular carcinoma from 2024-2025... Timing of y90 dose delivery for solitary HCC does not appear to significantly impact dose delivery to tumor or surrounding normal tissue. Second week delivery resulted in significantly higher sphere concentration in the tumor than in week one. Clinical and radiographic outcomes demonstrate similar efficacy and safety profiles regardless of delivery timing."

Hepatocellular Cancer • Oncology • Solid Tumor

Pre-Procedure MELD 3.0 is a Predictor of Short-Term Mortality and Impaired Liver Function Following Yttrium-90 Radioembolization (SIO 2026) - "Materials and TARE procedures performed using TheraSphere (Boston Scientific Corporation... Elevated pre-procedure MELD 3.0 reflects elevated risk for mortality and impaired synthetic liver function following TARE with various dosing strategies and treatment intents. Scores of 10 and 20 are reasonable thresholds to consider while discussing the elevated risk of impaired liver function and mortality, as 1 in 5 patients exceeding each threshold experienced the respective AE. Future multivariate analysis will determine whether pre-procedure MELD 3.0 modifies risk in patients stratified by non-tumor liver absorbed dose, and whether this effect can be predicted using a Tc-99mmacroaggregated albumin mapping study prior to TARE."

Hepatology