Initial Clinical Experience with a Novel Glass Radiopaque Yttrium-90 Radioembolization Microsphere for Treating Malignant Liver Tumors

Wednesday, March 8, 2023

3:54 PM – 4:03 PM

Location: Phoenix Convention Center, 224AB

Abstract Speaker(s)

Andrew Holden, ONZM, MBChB, FRANZCR, EBIR

Associate Professor
Aukland District Health Board / Auckland Hospital

Disclosure(s): Boston Scientific: Advisory Committee or Review Panel Member (Ongoing); Gore: Advisory Committee or Review Panel Member (Ongoing); Medtronic: Advisory Committee or Review Panel Member (Ongoing); Philips: Advisory Committee or Review Panel Member (Ongoing)

Author/Co-author(s)

Robert J. Abraham, MD, FSIR, FRCPC

Professor
Dalhousie University/QEII Health Sciences Center
Aravind Arepally, MD, FSIR

Interventional Radiology
Piedmont Healthcare
DL

David Liu, MD FRCPC FSIR

Associate Clinical Professor School of Biomedical Engineering
Vancouver Imaging
Cheenu Kappadath, PhD

Professor
University of Texas MD Anderson Cancer Center
MG

Marc Gregoire, P. Eng

VP R&D and Nuclear Operations
ABK Biomedical Inc.
AV

Amit Verma, DrPH, MPH

Clinical Program Director
ABK Biomedical Inc.
DD

David Dobrowski, n/a

VP Clinical Development & Regulatory Affairs
ABK Biomedical Inc.

Disclosure(s):

Andrew Holden, ONZM, MBChB, FRANZCR, EBIR: Boston Scientific: Advisory Committee or Review Panel Member (Ongoing); Gore: Advisory Committee or Review Panel Member (Ongoing); Medtronic: Advisory Committee or Review Panel Member (Ongoing); Philips: Advisory Committee or Review Panel Member (Ongoing)

Aravind Arepally, MD, FSIR: ABK Biomedical: Salaried Employee (Ongoing); Siemens Healthineers: Salaried Employee (Terminated, September 1, 2022); Trisalus Life Sciences: Intellectual Property Rights (Ongoing), Ownership Interest (Ongoing); WL Gore & Associates: Consultant (Ongoing)

Purpose:

To describe early human clinical experience with radiopaque, imageable glass Yttrium-90 (Y-90) radioembolic microspheres for malignant liver tumors.

Materials and Methods:

Eye90 microspheres® (Eye90) is a unique radiopaque glass radioactive Y-90 microsphere {1} allowing for confirmation of tumor targeting with conventional Computed Tomography (CT). In a prospective clinical trial, five patients to date underwent Eye90 treatment. Key inclusion criteria: liver only hepatocellular carcinoma, total lesion length < 9 cm, one lesion > 2 cm, Child–Pugh A, BCLC A-B. Prospective partition dosimetry was used in all patients after conventional mapping. Eye90 was injected selectively into targeted hepatic arteries in all patients. Post Eye90 4 Phase CT, TOF PET/CT, and SPECT/CT imaging and dosimetry analysis was used to quantify and compare microsphere distribution. Safety data and 3-month mRECIST response was collected.

Results:

Technical success was 100%. Table 1 details lesion and dosimetry parameters. Tumor targeting was confirmed through Eye90 radiopacity distributed through tumor on unenhanced CT and correlated well with post procedure TOF PET/CT and Bremsstrahlung SPECT/CT. Fusion of pre and post unenhanced CT demonstrated Eye90 radiopacity correlating to enhancing tumor tissue. Significant mRECIST tumor response was demonstrated. There were no treatment specific grade 3 toxicities.

Conclusion:

Eye90 microspheres provide the ability to confirm tumor targeting and demonstrate high spatial resolution of radiopaque microsphere distribution with CT imaging that correlated strongly with SPECT/CT and TOF PET/CT. Eye90 radiopacity may provide opportunity for future CT based post treatment dosimetry.