ABK Biomedical has announced the treatment of the first subject in the Route90 US IDE pivotal study of Eye90 microspheres in hepatocellular carcinoma (HCC).
Eye90 is claimed to be the first and only in-procedure imageable Y90 microspheres device.
The clinical trial is intended to assess the efficacy and safety of Eye90 microspheres in patients living with unresectable HCC.
Dr Eric Wang of Charlotte Radiology conducted the first Eye90 microspheres radioembolisation procedure.
Wang said: “Eye90 radioembolisation represents an advancement in liver-directed HCC therapy. Eye90 microspheres with multi-modality imaging, controlled visible administration and personalised dosimetry are advancing the field of radioembolisation.
“We’re excited to be a part of this pivotal study and look forward to establishing the effectiveness and safety of this new Y90 radioembolisation technology.”
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The study’s co-primary endpoints include the response rates of HCC tumours and the duration of response to Eye90 microspheres treatment.
Furthermore, the trial comprises endpoints for assessing safety and capability to carry out post-treatment CT-dosimetry with imageable microspheres, as well as potential benefits of intra-procedural visualisation.
ABK biomedical clinical and regulatory affairs vice-president David Dobrowski said: “While Y90 radioembolisation is established as a safe and effective therapy for the treatment of HCC, rigorous prospective clinical studies are needed to establish credible data to support FDA PMA approval.
“The Route90 study will collect the high-quality data long needed with Y90 radioembolisation therapy, establishing a new standard of treatment.”