CIO 2022-2 Embolization of Primary and Secondary Renal Cell Carcinoma Tumors with the GPX Embolic Device

Purpose: The GPX Embolic System is a novel embolic agent designed for use in durable and preoperative transcatheter embolization procedures. The GPX Embolic Material is a low-viscosity fluid before delivery that solidifies in response to physiological ionic strength. The material follows vascular flow and is designed for deep distal penetration of distally flowing vessels and complex vessel beds. Preclinical studies have demonstrated long-term occlusion without recanalization as well as desirable handling characteristics. A clinical study is ongoing to examine the use of the GPX Embolic Device in the peripheral vasculature, including interventional oncology applications. The primary objectives of this study are to evaluate the safety and early indicators of performance for the GPX Embolic Device. This presentation will focus on embolization of primary and secondary renal cell carcinoma (RCC) tumors.

Materials and Methods: This is a single-arm, multicenter, open-label, nonrandomized, prospective, first-in-human feasibility study evaluating the use of the GPX Embolic Device in the peripheral vasculature. Trial enrollment consists of 20 participants with various clinical needs appropriate for peripheral embolization, including various primary and secondary tumors. Technical success (including imaging follow-up, if available), freedom from adverse events, and handling and performance characteristics are being assessed.

Results: The GPX Embolic Device has been used in multiple primary and secondary RCC cases to date. All but one of these cases required embolization of multiple tumor-supplying vessels (up to five). In these procedures, the GPX Embolic Device fully embolized the targeted vessels, including distal occlusion of complex vessels and vessel beds, and exhibited good visibility during and after material delivery. Target regions were assessed as fully occluded at the first angiogram (taken immediately after delivery), and the procedures were considered technical successes. No device-related adverse events or severe adverse events were observed in these procedures.

Conclusions: Primary and secondary RCC embolizations have been promising with the GPX Embolic Device. These cases have met the desired endpoints and delivered good clinical outcomes. These embolizations will be further explored in a larger pivotal study.