Use of an anti-reflux catheter to improve tumor targeting for holmium-166 radioembolization—a prospective, within-patient randomized study
Caren van Roekel, Andor F. van den Hoven, Remco Bastiaannet, Rutger C. G. Bruijnen, Arthur J. A. T. Braat, Bart de Keizer, Marnix G. E. H. Lam, Maarten L. J. Smits
Abstract
Abstract Purpose The objective of this study was to investigate whether the use of an anti-reflux catheter improves tumor targeting for colorectal cancer patients with unresectable, chemorefractory liver metastases (mCRC) treated with holmium-166 ( 166 Ho)-radioembolization. Materials and methods In this perspective, within-patient randomized study, left and right hepatic perfusion territories were randomized between infusion with a Surefire® anti-reflux catheter or a standard microcatheter. The primary outcome was the difference in tumor to non-tumor (T/N) activity distribution. Secondary outcomes included the difference in infusion efficiency, absorbed doses, predictive value of 166 Ho-scout, dose-response relation, and survival. Results Twenty-one patients were treated in this study (the intended number of patients was 25). The median T/N activity concentration ratio with the use of the anti-reflux catheter was 3.2 (range 0.9–8.7) versus 3.6 (range 0.8–13.3) with a standard microcatheter. There was no difference in infusion efficiency (0.04% vs. 0.03% residual activity for the standard microcatheter and anti-reflux catheter, respectively) (95%CI − 0.05–0.03). No influence of the anti-reflux catheter on the dose-response rate was found. Median overall survival was 7.8 months (95%CI 6–13). Conclusion Using a Surefire® anti-reflux catheter did not result in a higher T/N activity concentration ratio in mCRC patients treated with 166 Ho-radioembolization, nor did it result in improved secondary outcomes measures. Trial registration clinicaltrials.gov identifier: NCT02208804