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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).
- Source :
- CardioVascular & Interventional Radiology; Aug2022, Vol. 45 Issue 8, p1057-1063, 7p
- Publication Year :
- 2022
-
Abstract
- Purpose: To investigate the biodistribution of holmium-166 microspheres (<superscript>166</superscript>Ho-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 ≤ 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 (<superscript>99m</superscript>Tc-MAA). The perfused liver volume is segmented from the CBCT and <superscript>166</superscript>Ho-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. Discussion: This study aims to find the optimal administration dose of adjuvant radioembolization with <superscript>166</superscript>Ho-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. Trial registration: Clinicaltrials.gov identifier: NCT03437382. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01741551
- Volume :
- 45
- Issue :
- 8
- Database :
- Complementary Index
- Journal :
- CardioVascular & Interventional Radiology
- Publication Type :
- Academic Journal
- Accession number :
- 158137712
- Full Text :
- https://doi.org/10.1007/s00270-022-03162-7