Surefire Infusion system vs. standard Microcatheter use during holmium-166 radioembolization for the treatment of colorectal liver metastases. - SIM trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* 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.

•* WHO (World health organization) performance score > 2
•* Inadequate bone marrow function (hemoglobin < 6.0 mmol/l, leukocyte count < 3.0 x 10^9/l, platelet count < 75x 10^9/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.

发起方

niversitair Medisch Centrum Utrecht