Imageable Radioembolization Microspheres for Treatment of Unresectable Hepatocellular Carcinoma: Interim Results from a First-in-Human Trial

• Published in: Journal of vascular and interventional radiology Vol. 35; no. 10; pp. 1464 - 1473.e1
• Main Authors: Abraham, Robert J., Arepally, Aravind, Liu, David, Lewandowski, Robert, Kappadath, S. Cheenu, Verma, Amit, Dobrowski, David, Holden, Andrew
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2024
• Subjects: Aged; Carcinoma, Hepatocellular - diagnostic imaging; Carcinoma, Hepatocellular - pathology; Carcinoma, Hepatocellular - radiotherapy; Carcinoma, Hepatocellular - therapy; Embolization, Therapeutic - adverse effects; Female; Humans; Liver Neoplasms - diagnostic imaging; Liver Neoplasms - pathology; Liver Neoplasms - radiotherapy; Liver Neoplasms - therapy; Male; Microspheres; Middle Aged; Pilot Projects; Predictive Value of Tests; Prospective Studies; Radiopharmaceuticals - administration & dosage; Radiopharmaceuticals - adverse effects; Single Photon Emission Computed Tomography Computed Tomography; Time Factors; Tomography, Emission-Computed, Single-Photon; Treatment Outcome; Yttrium Radioisotopes - administration & dosage; CTCAE; FDA; PR; 90Y; AE; MR; mRECIST; TACE; HCC; T:N; SPECT; CR; DS; CT; ECOG; SAE; IRB; PET
• ISSN: 1051-0443; 1535-7732; 1535-7732
• DOI: 10.1016/j.jvir.2024.06.023

To determine 6-month interim safety, effectiveness, and multimodal imageability of imageable glass microsphere yttrium-90 (90Y) radioembolization for unresectable hepatocellular carcinoma (HCC) in a first-in-human trial. Imageable microspheres (Eye90 Microspheres; ABK Biomedical, Halifax, Nova Scotia, Canada), a U.S. Food and Drug Administration (FDA) Breakthrough-Designated Device consisting of glass radiopaque 90Y microspheres visible on computed tomography (CT) and single photon emission CT (SPECT), were used to treat 6 subjects with unresectable HCC. Patients underwent selective (≤2 segments) treatment in a prospective open-label pilot trial. Key inclusion criteria included liver-only HCC, performance status ≤1, total lesion diameter ≤9 cm, and Child-Pugh A status. Prospective partition dosimetry was utilized. Safety (measured by Common Terminology Criteria for Adverse Events [CTCAE] v5), multimodal imageability on CT and SPECT, and 3- and 6-month imaging response by modified Response Evaluation Criteria in Solid Tumors on magnetic resonance (MR) imaging were evaluated. Seven tumors in 6 subjects were treated and followed to 180 days. Administration success was 100%. Microsphere distribution measured by radiopacity on CT correlated with SPECT. Ninety-day target lesion complete response (CR) was observed in 3 of 6 subjects (50%) and partial response (PR) in 2 (33.3%). At 180 days, target lesion CR was maintained in 3 subjects (50%) and PR in 1 (16.7%). Two subjects could not be reassessed, having undergone intervening chemoembolization. All subjects reported adverse events (AEs), and 5 reported AEs related to treatment. There were no treatment-related Grade ≥3 AEs. Radioembolization using imageable microspheres was safe and effective in 6 subjects with unresectable HCC at 6-month interim analysis. Microsphere distribution by radiopacity on CT correlated with radioactivity distribution by SPECT, providing previously unavailable CT-based tumor targeting information. [Display omitted]