Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)
试验速览
- 阶段
- 2 期
- 发起方
- UMC Utrecht
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
研究概览
简要总结
The objective of the SIM trial is to investigate whether using the Surefire Infusion System during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity concentration ratio, compared with using a standard end-hole microcatheter.
详细描述
Study design: clinical within-subject randomized controlled trial.
Study population: 25 patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases.
Intervention: scout and therapeutic doses of holmium-166 microspheres will be administered in the left and right hepatic artery during two sequential angiography procedures on the same day. In all subjects, the use of the Surefire Infusion System and the standard end-hole catheter will be randomly allocated to the infusion site (left and right hepatic artery).
Baseline and follow-up investigation: at baseline and during follow-up, patients will undergo physical examination and laboratory investigations for toxicity assessment, and a whole-body 18F-FDG-PET + dual-phase liver CT (at baseline and 3-months follow-up) for tumor response assessment. After the scout procedure and therapeutic procedure, a holmium-166 SPECT/CT will be obtained for the assessment of the microsphere distribution.
Main study parameters/endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histopathologically confirmed diagnosis of adenocarcinoma of the colon or rectum
- •Hepatic metastases with measurable morphological appearance (≥ 1 cm) on cross sectional imaging, located in the right and left hepatic arterial perfusion territory
- •Unresectable, liver dominant disease
- •Progressive disease after second line chemotherapy or no further chemotherapeutical treatment options due to severe side effects or unwillingness of the patient to undergo systemic chemotherapy
- •Age ≥ 18 years
- •Expected adequacy of follow-up
排除标准
- •World health organization performance score > 2
- •Inadequate bone marrow function (hemoglobin < 6.0 mmol/l, leukocyte count < 3.0 x 109/l, platelet count < 75x 109/l), inadequate liver function (bilirubin > 35 µmol/l, aspartate aminotransferase / alanine aminotransferase (AST/ALT) > 5 x upper limit of normal (ULN)) or inadequate renal function (creatinine > 1.5 x ULN)
- •Prior hemihepatectomy
- •Compromised biliary system (biliary stent or hepaticojejunostomy)
- •Child Pugh score B7 or worse
- •Active hepatitis B or C
- •Main portal vein thrombosis on CT (or previous portal vein embolization)
- •Severe celiac axis stenosis on CT
- •Unsuitable hepatic arterial anatomy on CT
- •Treatment with systemic chemotherapy within 4 weeks prior to radioembolization
- •Previous participation in a study classified as class III by a radiation safety committee
- •Bleeding diathesis
- •Pregnancy or breast feeding
- •Life expectancy < 3 months
- •Patients who are declared incompetent
- •Any condition that prevents from safe treatment with radioembolization
结局指标
主要结局
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
时间窗: 5 days after treatment
次要结局
- Overall survival(From date of treatment until the date of death from any cause, assessed up to 1 year)
- Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET(3 months after treatment)
- Infusion efficiency(On the day of treatment)
- Posttreatment tumor response on CT and 18F-FDG-PET(3 months after treatment)
- Clinical and laboratory toxicity(Up to 3 months after treatment)
- Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT(5 days after treatment)
- Predictive value of the holmium-166 scout dose(On the day of treatment)
研究者
Maurice A.A.J. van den Bosch
Prof. dr.
UMC Utrecht