A Phase I First in Human Study of Embrace™ a Polyethylene Glycol Based Liquid Embolic in the Embolization of Malignant and Benign Hypervascular Tumors.

Abstract

To investigate the safety and efficacy of an aqueous polyethylene glycol (PEG) based liquid embolic Embrace HES in the treatment of benign and malignant hypervascular tumors. A prospective, single-arm, multicenter study included eight patients, 5 males and 3 females median age 58.5 (30-85), who underwent embolization in eight tumors between October 2019 and May 2020. Technical success was defined as successful delivery of HES to the index vessel with disappearance of >90% of the targeted vascular enhancement, or for portal vein embolization, occlusion of the portal branches to the liver segments for future resection. The volume of HES administered, ease of use (Likert scale), administration time and adverse events were recorded. Evaluation at 7, 30 and 90 days via clinical assessment and blood testing; and follow-up imaging at 30 days. Eight patients were enrolled with 10 embolizations performed in 8 lesions. Tumors included Hepatocellular carcinoma (n=4), Renal Angiomyolipoma (n=3) and Intrahepatic Cholangiocarcinoma (n=1). Technical success was 100% and average ease of use was 3.3 +/- 1.0 standard deviation. HES delivery time was 1-28 minutes (median 16.5) and HES volume injected was 0.4-4.0mL (median 1.3). All patients reached 30 day follow-up with imaging and 6 reached 90 day follow-up. There were 3 serious adverse events in 2 patients which were unrelated to the embolic agent. HES resulted in a 100% embolization technical success. Product ease of use was acceptable and no target vessel recanalization was noted in follow up imaging at 30 days.