Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial

Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial: Background:
An anti-reflux catheter (ARC) may increase the tumor absorbed dose during radioembolization (RE) by elimination of particle reflux and its effects on hemodynamics. Since the catheter is fixed in a centro-luminal position, it may also increase the predictive accuracy of a scout dose administration before treatment. The purpose of the SIM trial is to compare the effects of ARC use during RE with holmium-166 (
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Ho) microspheres in patients with colorectal liver metastases (CRLM), with the use of a standard end-hole microcatheter.Methods/DesignA within-patient randomized controlled trial (RCT) will be conducted in 25 patients with unresectable chemorefractory liver-dominant CRLM. Study participants will undergo a
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Ho scout dose procedure in the morning and a therapeutic procedure in the afternoon. The ARC will be randomly allocated to the left/right hepatic artery, and a standard microcatheter will be used in the contralateral artery. SPECT/CT imaging will be performed for quantitative analyses of the microsphere distribution directly after the scout and treatment procedure. Baseline and follow-up investigations include
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F-FDG-PET + liver CT, clinical and laboratory examinations. The primary endpoint is the comparison of tumor to non-tumor (T/N) activity ratio in both groups. Secondary endpoints include comparisons of mean absorbed dose in tumors and healthy liver tissue, infusion efficiency, the predictive value of
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Ho scout dose for tumor response. In the entire cohort, a dose-response relationship, clinical toxicity, and overall survival will be assessed. The sample was determined for the expectation that the ARC will increase the T/N ratio by 25 % (mean T/N ratio 2.0 vs. 1.6).DiscussionThe SIM trial is a within-patient RCT that will assess whether
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Ho RE treatment can be optimized by using an ARC.Trial registrationThe SIM trial is registered at clinicaltrials.gov (NCT02208804). Registered on 31 July 2014.

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