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

Safety and Feasibility of Yttrium-90 Glass Microsphere Radiation Therapy in Recurrent Glioblastoma: Results from the first 12 patients treated in the FRONTIER trial (SNO 2025) - "Results from this initial cohort suggest IA Y90-microsphere therapy is technically feasible and well-tolerated in rGBM. Further investigation is warranted."

Clinical • Brain Cancer • Glioblastoma • Hepatocellular Cancer • Solid Tumor

Safety and Feasibility of Yttrium-90 Glass Microsphere Radiation Therapy in Recurrent Glioblastoma: Results from the first 12 patients treated in the FRONTIER trial (WFNOS 2025) - "Results from this initial cohort suggest IA Y90-microsphere therapy is technically feasible and well-tolerated in rGBM. Further investigation is warranted."

Clinical • Brain Cancer • Glioblastoma • 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=60 | Recruiting | Sponsor: AstraZeneca | N=100 ➔ 60

Enrollment change • Hepatocellular Cancer • Oncology • Solid Tumor

Comparative Efficacy and Safety of Yttrium-90 Glass vs Resin-Based Microspheres in Hepatocellular Carcinoma Treatment: A Systematic Review and Meta-Analysis (ACG 2025) - "Glass (TheraSphere) and resin (SIR-Spheres) based microspheres are used, but comparative outcomes remain debated... Five studies with 460 patients (252 glass, 208 resin) were analyzed – two retrospective non-randomized trials and three retrospective cohort studies. The population included 376 males (81.7%) with mean or median ages ranging from 60 to 69 years. Baseline characteristics are summarized in Table 1."

Retrospective data • Review • Anorexia • Fatigue • Hepatocellular Cancer • Oncology • Solid Tumor

Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk (clinicaltrials.gov) - P2 | N=84 | Suspended | Sponsor: Northwestern University | Trial primary completion date: Jul 2025 ➔ Jul 2026

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 microspheres (ESMO 2025) - P | "Background PROACTIF was an all comers, multicenter, post approval study that evaluated the effectiveness and safety of Y90 glass microspheres (TheraSphere™) for the treatment of liver cancers...Overall patients had long OS, particularly for patients with subsequent surgery across all BCLC stages. When deciding HCC management, Y90 should be considered a treatment option by multidisciplinary tumor boards."

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

Safety and Feasibility of Yttrium-90 Glass Microspheres in Recurrent Glioblastoma: Results from the first 12 patients treated in the FRONTIER trial (EANO 2025) - "Results from this initial cohort of the FRONTIER trial suggest IA Y90 glass microsphere therapy is technically feasible and well-tolerated in patients with recurrent GBM. The observed dose-response relationship warrants further investigation of this modality as a potential treatment option."

Clinical • Brain Cancer • Glioblastoma • Hepatocellular Cancer • Oncology • Solid Tumor

Investigation of the Dosimetry Differences Between Pre-Therapy SPECT/CT and Post-Therapy PET/CT Scan in Selective Internal Radiation Therapy (SIRT) (EANM 2025) - "Materials and Methods Twenty patients who received SIRT using 90Y-Theraspheres (Boston Scientific) were selected...However, there are large tumour absorbed dose differences between pre- and post-therapy imaging suggesting opportunity for optimisation of tumour and liver dose. This arises from a variety of factors including a change in activity distribution, PVE, segmentation methods and inter-operator variability."

Elevated Baseline C-Reactive Protein Is Associated with Treatment Failure and Shorter Survival After Radioembolization with Yttrium-90 Glass Microspheres in Hepatocellular Carcinoma: Validation of LI-RADS R-TRA v2024 [WITHDRAWN] (EANM 2025) - No abstract available

Hepatocellular Cancer • Oncology • Solid Tumor • CRP

Is the Planned Dose Achieved in Yttrium-90 Glass Microsphere Radioembolization? An Examination of Factors Influencing Residual Catheter Activity [WITHDRAWN] (EANM 2025) - No abstract available

Correlation of Voxel-Based Dosimetric Parameters With Progression-Free Survival and Overall Survival After Yttrium-90 Glass Microsphere Radioembolisation in Hepatocellular Carcinoma (EANM 2025) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

ROWAN: TheraSphere With Durvalumab and Tremelimumab for HCC (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Boston Scientific Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatocellular Cancer • Oncology • Solid Tumor

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University of Miami | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2030 ➔ Nov 2030 | Initiation date: Aug 2025 ➔ Nov 2025 | Trial primary completion date: Aug 2030 ➔ Nov 2030

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

First-in-India Experience with 90Y-BhabhaSphere: An Indigenous 90Y-TheraSphere Biosimilar for Transarterial radioembolization of Hepatic Malignancies. (PubMed, Br J Radiol) - "This study highlights a key advantage of 90Y-BhabhaSphere: its significantly higher specific activity (approximately 6000 Bq/sphere) compared to commercially available 90Y-TheraSphere (2700 Bq/sphere). This suggests a potential for delivering higher tumor doses whileminimizing radiation exposure to healthy liver tissue, thereby reducing the risk of radiation-induced liver damage."

Journal • Hepatocellular Cancer • Liver Cancer • Oncology

Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: University of California, San Francisco

New trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Yttrium-90 glass microsphere radioembolization as frontline treatment for hepatocellular carcinoma with localized portal vein invasion. (PubMed, Eur Radiol) - "Question What is the optimal radioembolization approach and its outcome for hepatocellular carcinoma with localized portal vein invasion (Vp1-3) in patients with preserved liver function? Findings A tumor absorbed dose exceeding 600 Gy via a tandem approach achieved complete response rates above 80% and median overall survival longer than 49.5 months. Clinical relevance Ablative radioembolization, delivering a tumor absorbed dose exceeding 600 Gy via a tandem approach, should be considered for hepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-3) in patients with preserved liver function and no extrahepatic spread."

Journal • Cardiovascular • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Liver Directed Therapy “Embolotherapy” with a Focus on Radioembolization (SNMMI 2025) - "Employing two FDA-approved devices—glass microspheres (Therasphere) and resin microspheres—suitable for advanced HCC and progressive colorectal liver metastases (CLM) respectively, this educational exhibit will impart information on evidence-based best practices as well as provide anonymized procedure examples... TARE employs minimally embolic microspheres loaded with Yttrium-90 (Y90), a β-emitting isotope, for selective internal radiation. Identifying unexpected extrahepatic shunting to the lungs, bowel, and skin during pretherapy planning is crucial; it may necessitate additional pre-therapy embolizations or dose adjustments before therapeutic administration of Y90 microspheres. Accurate determination of the lung shunt percentage is vital for appropriate dosage calibration."

Cardiovascular • Hepatocellular Cancer • Hepatology • Oncology • Pneumonia • Solid Tumor

Digital twins for optimising intra-arterial therapy in liver cancer. (PubMed, Comput Biol Med) - "The digital twin allowed us to reproduce the intra-arterial administration of Therasphere® in a patient diagnosed with two HCCs...In addition, the catheter's tip inclination with respect to the hepatic arterial vessels was also proved to influence the microspheres' delivery to the tumor and the non-tumor tissues. The developed digital twin and optimisation strategy could help the clinicians in personalizing the SIRT, thus improving the targeting of the tumor(s) while preserving healthy tissues."

Journal • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

The relationship between yttrium-90 glass microspheres specific activity, particle density and treatment outcomes in HCC and mCRC. (PubMed, Eur J Nucl Med Mol Imaging) - "No efficacy treatment benefit for week 2 versus week 1 was observed in TARGET or EPOCH, but week 2 treatment trended towards a higher rate and severity of specific AEs."

Clinical • Journal • Colorectal Cancer • Hepatocellular 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 | Active, not recruiting ➔ Recruiting | N=12 ➔ 36 | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Mar 2026

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Neutropenia • Oncology • Solid Tumor

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: University of Miami

New P2 trial • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Clinical and dosimetric considerations for yttrium-90 glass microspheres radioembolization of intrahepatic cholangiocarcinoma, metastatic colorectal carcinoma, and metastatic neuroendocrine carcinoma: recommendations from an international multidisciplinary working group. (PubMed, Eur J Nucl Med Mol Imaging) - "Consensus recommendations are provided to guide clinical and dosimetry approaches for 90Y glass microsphere radioembolization in iCCA, mCRC and mNET."

Journal • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Endocrine Cancer • Hepatology • Neuroendocrine Tumor • Oncology • Palliative care • 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 | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk (clinicaltrials.gov) - P2 | N=84 | Suspended | Sponsor: Northwestern University | Trial completion date: Jul 2025 ➔ Jul 2026 | Recruiting ➔ Suspended | Trial primary completion date: Jul 2024 ➔ Jul 2025

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

Boston Scientific: Advancing HCC Management: SIRT in Downstaging HCC (LCS 2025) - "The symposium will also present the latest clinical evidence and best practices for integrating SIRT with TheraSphere Y-90 Therapy with systemic therapies, focusing on optimal patient selection and treatment strategies. The lectures and clinical cases discussion will offer an opportunity to enhance understanding and application of cutting-edge HCC management techniques."

Gastrointestinal Cancer • Hepatocellular Cancer