%0 Journal Article
%T Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial).
%A Hendriks P
%A Rietbergen DDD
%A van Erkel AR
%A Coenraad MJ
%A Arntz MJ
%A Bennink RJ
%A Braat AE
%A Crobach S
%A van Delden OM
%A Dibbets-Schneider P
%A van der Hulle T
%A Klümpen HJ
%A van der Meer RW
%A Nijsen JFW
%A van Rijswijk CSP
%A Roosen J
%A Ruijter BN
%A Smit F
%A Stam MK
%A Takkenberg RB
%A Tushuizen ME
%A van Velden FHP
%A de Geus-Oei LF
%A Burgmans MC
%A  
%J Eur J Nucl Med Mol Imaging
%V 51
%N 7
%D 2024 Jun 8
%M 38329507
%F 10.057
%R 10.1007/s00259-024-06630-z
%X <B>OBJECTIVE: </B>The aim of this study was to investigate the biodistribution of (super-)selective trans-arterial radioembolization (TARE) with holmium-166 microspheres (166Ho-MS), when administered as adjuvant therapy after RFA of HCC 2-5 cm. The objective was to establish a treatment volume absorbed dose that results in an absorbed dose of ≥ 120 Gy on the hyperemic zone around the ablation necrosis (i.e., target volume).<BR><B>METHODS: </B>In this multicenter, prospective dose-escalation study in BCLC early stage HCC patients with lesions 2-5 cm, RFA was followed by (super-)selective infusion of 166Ho-MS on day 5-10 after RFA. Dose distribution within the treatment volume was based on SPECT-CT. Cohorts of up to 10 patients were treated with an incremental dose (60 Gy, 90 Gy, 120 Gy) of 166Ho-MS to the treatment volume. The primary endpoint was to obtain a target volume dose of ≥ 120 Gy in 9/10 patients within a cohort.<BR><B>RESULTS: </B>Twelve patients were treated (male 10; median age, 66.5 years (IQR, [64.3-71.7])) with a median tumor diameter of 2.7 cm (IQR, [2.1-4.0]). At a treatment volume absorbed dose of 90 Gy, the primary endpoint was met with a median absorbed target volume dose of 138 Gy (IQR, [127-145]). No local recurrences were found within 1-year follow-up.<BR><B>CONCLUSIONS: </B>Adjuvant (super-)selective infusion of 166Ho-MS after RFA for the treatment of HCC can be administered safely at a dose of 90 Gy to the treatment volume while reaching a dose of ≥ 120 Gy to the target volume and may be a favorable adjuvant therapy for HCC lesions 2-5 cm.<BR><B>BACKGROUND: </B>Clinicaltrials.gov NCT03437382 . (registered: 19-02-2018).