Author information

¹Department of Diagnostic Radiology, Dalhousie University, Halifax, NS, Canada; ABK Biomedical Inc., Halifax, NS, Canada. Electronic address: robert.abraham@dal.ca.

²ABK Biomedical Inc., Halifax, NS, Canada. Electronic address: a.arepally@abkbiomedical.com.

³Vancouver Imaging, University of British Columbia, Vancouver, BC, Canada. Electronic address: Dave.Liu@vch.ca.

⁴Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: r-lewandowski@northwestern.edu.

⁵Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: skappadath@mdanderson.org.

⁶ABK Biomedical Inc., Halifax, NS, Canada.

⁷Diagnostic Radiology, Auckland City Hospital, Auckland, New Zealand. Electronic address: AndrewH@adhb.govt.nz.

Abstract

Purpose: To Describe 6-Month safety, efficacy and multimodal imageability after imageable glass Yttrium-90 radioembolization for unresectable Hepatocellular Carcinoma (HCC) in a First-in Human Trial METHODS: Eye90 microspheres® (Eye90), an FDA Breakthrough Designated Device, are glass radiopaque Y-90 microspheres visible on CT and SPECT/CT. Six subjects with unresectable HCC underwent selective (≤ 2 segments) Eye90 treatment in a prospective open-label pilot trial. Key inclusion criteria included liver only HCC, ECOG ≤ 1, total lesion length ≤ 9 cm and Child-Pugh A. Prospective partition dosimetry was utilized. Safety, biochemistry, toxicity, adverse events (AE), multimodal imageability on CT and SPECT/CT and 3 and 6-month MRI local modified RECIST (mRECIST) response was evaluated.

Results: 6 subjects with HCC (7 lesions) were treated with Eye90 and followed to 180 days. Administration success was 100%. Eye90 CT radiopacity distribution correlated with SPECT/CT. Target lesion complete response was observed in 3 of 6 subjects (50%) and partial response in 2 (33.3%). Two subjects could not be assessed at 180 days. At 180 days, target lesion complete response was maintained in 3 subjects (50%) and partial response in 1 (16.7%). All subjects reported AEs, and 5 reported AEs related to treatment. There were no treatment related serious AEs.

Conclusions: Eye90 was safe and effective in six subjects with unresectable HCC up to 6 months. Eye90 was imageable via CT and SPECT/CT with correlation between CT radiopacity and SPECT/CT radioactivity distribution. Eye90 provided previously unavailable CT based tumor targeting information.