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Open Access 01-12-2016 | Study protocol

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

Authors: Andor F. van den Hoven, Jip F. Prince, Rutger C. G. Bruijnen, Helena M. Verkooijen, Gerard C. Krijger, Marnix G. E. H. Lam, Maurice A. A. J. van den Bosch

Published in: Trials | Issue 1/2016

Abstract

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 (¹⁶⁶Ho) microspheres in patients with colorectal liver metastases (CRLM), with the use of a standard end-hole microcatheter.

Methods/Design

A within-patient randomized controlled trial (RCT) will be conducted in 25 patients with unresectable chemorefractory liver-dominant CRLM. Study participants will undergo a ¹⁶⁶Ho 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 ¹⁸F-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 ¹⁶⁶Ho 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).

Discussion

The SIM trial is a within-patient RCT that will assess whether ¹⁶⁶Ho RE treatment can be optimized by using an ARC.

Trial registration

The SIM trial is registered at clinicaltrials.gov (NCT02208804). Registered on 31 July 2014.

Available only for authorised users

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Title: Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial
Authors: Andor F. van den Hoven
Jip F. Prince
Rutger C. G. Bruijnen
Helena M. Verkooijen
Gerard C. Krijger
Marnix G. E. H. Lam
Maurice A. A. J. van den Bosch
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1643-3

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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