Evaluation of the preventive effect of pentoxifylline and ursodeoxycholic acid to radiation induced liver toxicity after brachytherapy of liver metastases, assessed in a prospective randomised trial. - ELDORADO

niversity of Magdeburg0 个研究点目标入组 36 人开始时间: 2008年12月17日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•Age 18 to 85 or ECOG performance status of 0 or 1
•If female, postmenopausal or surgically sterilized
•Liver metastases scheduled for a CT/MRI-guided single or sequential interstitial HDR brachytherapy
•Non-cirrhotic liver
•Life expectancy longer than 6 months
•Willing and able to undergo all study procedures
•Having voluntarily provided written and fully informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•Women who are pregnant, lactating or who are of childbearing potential
•Liver cirrhosis
•Hepatitis B
•Hepatitis C
•Patients being clinically unstable
•Uncooperative, in the investigator’s opinion
•Having been previously enrolled in this study
•Participating in another therapy-modulating clinical trial
•Contraindication for MRI
•Contraindication or hypersensitivity to one or more components of Primovist, Ursodeoxycholic acid and/or Pentoxifylline
•Any prior irradiation therapy of the liver up to 6 months before inclusion
•Close affiliation with the investigational site; e.g. a close relative of the investigator
•Severe coronary artery disease
•Autoimmune diseases
•Acute bacterial endocarditis
•Patients with severe renal impairment (GFR below 45 mL/min/ according to the CKI EPI formula, calculated from a creatinine value obtained at the initial examination)
•Patients with medication of coumarins (vitamin K antagonists)

发起方

niversity of Magdeburg