Study protocol: adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients-a dose-finding study (HORA EST HCC Trial)

Hendriks, P.; Rietbergen, D.D.D.; Erkel, A.R. van; Coenraad, M.J.; Arntz, M.J.; Bennink, R.J.; Braat, A.E.; Crobach, A.S.L.P.; Delden, O.M. van; Hulle, T. van der; Klumpen, H.J.; Meer, R.W. van der; Nijsen, J.F.W.; Rijswijk, C.S.P. van; Roosen, J.; Ruijter, B.N.; Smit, F.; Stam, M.K.; Takkenberg, R.B.; Tushuizen, M.E.; Velden, F.H.P. van; Geus-Oei, L.F. de; Burgmans, M.C.; Dutch Hepatocellular Cholangiocarc

doi:doi:10.1007/s00270-022-03162-7

Purpose To investigate the biodistribution of holmium166 microspheres (166Ho-MS) when administered after radiofrequency ablation (RFA) of early-stage hepatocellular carcinoma (HCC). The aim is to establish a perfused liver administration dose that results in a tumoricidal dose of holmium-166 on the hyperaemic zone around the ablation necrosis (i.e. target volume). Materials and Methods This is a multicentre, prospective, dose-escalation study in HCC patients with a solitary lesion 2–5 cm, or a maximum of 3 lesions of B 3 cm each. The day after RFA patients undergo angiography and conebeam CT (CBCT) with (super)selective infusion of technetium-99 m labelled microalbumin aggregates (99mTcMAA). The perfused liver volume is segmented from the CBCT and 166Ho-MS is administered to this treatment volume 5–10 days later. The dose of holmium-166 is escalated in a maximum of 3 patient cohorts (60 Gy, 90 Gy and 120 Gy) until the endpoint is reached. SPECT/CT is used to determine the...Show morePurpose To investigate the biodistribution of holmium166 microspheres (166Ho-MS) when administered after radiofrequency ablation (RFA) of early-stage hepatocellular carcinoma (HCC). The aim is to establish a perfused liver administration dose that results in a tumoricidal dose of holmium-166 on the hyperaemic zone around the ablation necrosis (i.e. target volume). Materials and Methods This is a multicentre, prospective, dose-escalation study in HCC patients with a solitary lesion 2–5 cm, or a maximum of 3 lesions of B 3 cm each. The day after RFA patients undergo angiography and conebeam CT (CBCT) with (super)selective infusion of technetium-99 m labelled microalbumin aggregates (99mTcMAA). The perfused liver volume is segmented from the CBCT and 166Ho-MS is administered to this treatment volume 5–10 days later. The dose of holmium-166 is escalated in a maximum of 3 patient cohorts (60 Gy, 90 Gy and 120 Gy) until the endpoint is reached. SPECT/CT is used to determine the biodistribution of holmium-166. The endpoint is met when a dose of C 120 Gy has been reached on the target volume in 9/10 patients of a cohort. Secondary endpoints include toxicity, local recurrence, disease-free and overall survival. Discussion This study aims to find the optimal administration dose of adjuvant radioembolization with 166Ho-MS after RFA. Ultimately, the goal is to bring the efficacy of thermal ablation up to par with surgical resection for earlystage HCC patients.
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Study protocol: adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients-a dose-finding study (HORA EST HCC Trial)