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To describe early technical success and safety after radioembolization of HCC with multimodal imageable glass Y90 microspheres in the US IDE Pivotal Study (Route90). A unique imageable glass Y90 microsphere that provides beta radiation with multimodality imaging capabilities through CT is being evaluated for the treatment of LIRADS 5 or biopsy proven HCC. This device has received FDA Breakthrough Device designation. In this prospective study, enrollment of 120 subjects to achieve 100 evaluable subjects is planned. Subjects will undergo selective treatment for LIRADS 5 or biopsy proven HCC. Key inclusion criteria include Child-Pugh A, liver only HCC, ECOG ≤1, ≤3 lesions, single lesion ≤8 cm with sum of all lesions ≤12 cm. Prospective partition dosimetry will be used to determine activity to provide tumor absorbed dose ≥ 205 Gy. Y90 quantity (mass) will be determined based on perfused target volume to achieve a microsphere (MS) concentration in perfused volume of >15,000 MS/mL. Assessment of safety, ECOG, biochemistry, toxicity ≥ grade 3, related Treatment Emergent Serious Adverse Events and response evaluated by local modified RECIST, mRECIST, and RECIST 1.1 on 4-phase CT at 3-month intervals up to 12 months will be obtained. Volumes for liver, target perfused volume, tumor(s), ipsilateral lobe, contralateral lobe, caudate and spleen will be compared between baseline and 90-day imaging. Two subjects have been enrolled and successfully treated to date with three subjects awaiting screening. Subjects tolerated the procedure well, and there were no immediate complications or significant treatment related adverse events. Qualitative analysis shows multimodal imaging capability with visualization of imageable Y-90 MS on X-ray, Cone Beam CT (CBCT), 4-phase CT, SPECT/CT, and TOF PET/CT with good correlation between MS radiopacity and radioactivity in target tissue. MS radiopacity is retained in tumor on follow-up imaging. Interim safety and efficacy results for subjects reaching the 3-month follow-up period will be presented. Interim safety and efficacy results from the Route90 US IDE pivotal trial for treatment of unresectable HCC with imageable Y90 microspheres will be presented. Initial assessment confirms successful administration with no serious adverse events. This unique device provided multi-modality imaging capability on X-ray, CT, CBCT, SPECT/CT and TOF PET/CT and shows promise as an imaging biomarker for predicting tumor response and as a fiducial for subsequent SBRT or radiofrequency/microwave ablation if required.
Abraham et al. (Wed,) studied this question.