biostudies-literatureHendriks PHealth~Holland1057-1063https://www.ebi.ac.uk/biostudies/studies/S-EPMC9307549biostudies-literatureUnknown45(8)<h4>Purpose</h4>To investigate the biodistribution of holmium-166 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).<h4>Materials and methods</h4>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 ≤ 3 cm each. The day after RFA patients undergo angiography and cone-beam CT (CBCT) with (super)selective infusion of technetium-99 m labelled microalbumin aggregates (^99mTc-MAA). 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 ≥ 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.<h4>Discussion</h4>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 early-stage HCC patients.<h4>Trial registration</h4>Clinicaltrials.gov identifier: NCT03437382.Cardiovascular and interventional radiologyStudy Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial).PMC930754940-41200-98-9286Braat AECrobach ASLPvan Rijswijk CSPvan Velden FHPvan der Hulle TTakkenberg RBvan Delden OMvan der Meer RWRietbergen DDDStam MKDutch Hepatocellular Cholangiocarcinoma GroupCoenraad MJKlumpen HJRoosen JHendriks PArntz MJSmit FNijsen JFWvan Erkel ARBennink RJTushuizen MEBurgmans MCRuijter BNde Geus-Oei LFfalseStudy Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial).<h4>Purpose</h4>To investigate the biodistribution of holmium-166 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).<h4>Materials and methods</h4>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 ≤ 3 cm each. The day after RFA patients undergo angiography and cone-beam CT (CBCT) with (super)selective infusion of technetium-99 m labelled microalbumin aggregates (^99mTc-MAA). 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 ≥ 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.<h4>Discussion</h4>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 early-stage HCC patients.<h4>Trial registration</h4>Clinicaltrials.gov identifier: NCT03437382.2022-01-01T00:00:00Z2022 Aug2026-05-09T23:42:43.616Z2025-04-04T22:12:59.495ZS-EPMC93075493561886010.1007/s00270-022-03162-7