166钬放射性栓塞术中Surefire输注系统与标准微导管的应用比较：一项随机对照试验的研究方案
Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial.
作者信息
van den Hoven Andor F, Prince Jip F, Bruijnen Rutger C G, Verkooijen Helena M, Krijger Gerard C, Lam Marnix G E H, van den Bosch Maurice A A J
机构信息
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
出版信息
Trials. 2016 Oct 25;17(1):520. doi: 10.1186/s13063-016-1643-3.
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 (Ho) 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 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 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 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).
DISCUSSION
The SIM trial is a within-patient RCT that will assess whether Ho 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.
背景
抗反流导管（ARC）可通过消除颗粒反流及其对血流动力学的影响，在放射性栓塞（RE）期间增加肿瘤吸收剂量。由于该导管固定在管腔中心位置，它还可能提高治疗前模拟剂量给药的预测准确性。SIM试验的目的是比较在结直肠癌肝转移（CRLM）患者中，使用ARC进行RE与使用钬-166（Ho）微球，并使用标准端孔微导管的效果。
方法/设计：将对25例不可切除的化疗难治性以肝脏为主的CRLM患者进行患者内随机对照试验（RCT）。研究参与者将在上午接受Ho模拟剂量程序，下午接受治疗程序。ARC将随机分配至左/右肝动脉，对侧动脉使用标准微导管。在模拟剂量和治疗程序后，将立即进行SPECT/CT成像，以对微球分布进行定量分析。基线和随访调查包括F-FDG-PET +肝脏CT、临床和实验室检查。主要终点是两组中肿瘤与非肿瘤（T/N）活性比的比较。次要终点包括肿瘤和健康肝组织中平均吸收剂量的比较、灌注效率、Ho模拟剂量对肿瘤反应的预测价值。在整个队列中，将评估剂量反应关系、临床毒性和总生存期。确定样本量是期望ARC能使T/N比提高25%（平均T/N比为2.0对1.6）。
讨论
SIM试验是一项患者内RCT，将评估使用ARC是否可优化Ho RE治疗。
试验注册
SIM试验已在clinicaltrials.gov注册（NCT02208804）。于2014年7月31日注册。
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