Preventive effect of drugs on radiation damage to the liver.

Phase 1

Conditions: Irradiation damage to the liver after HDR-brachytherapy of liver metastases.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-002985-70-DE

Lead Sponsor: niversity of Magdeburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if a combination regimen of pentoxifylline and ursodeoxycholic acid provides a preventive effect regarding irradiation damage to liver parenchyma after HDR-brachytherapy.;Secondary Objective: To evaluate the relation between hepatocyte dysfunction as assessed in Primovist-enhanced MRI and changes in liver-specific and inflammatory laboratory values.<br>To evaluate the quality of live comparing both patient groups using the EQ-5D questionnaire and ECOG performance status.<br>To assess the safety of the study medication given after HDR brachytherapy.<br>;Primary end point(s): HDR-brachytherapy isodose that marks the border between damaged and functioning liver tissue (as defined by GD-EOB-DTPA-enhanced MR imaging).;Timepoint(s) of evaluation of this end point: 6 weeks, 3 months and 6 months after brachytherapy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in inflammatory and liver specific parameters.<br>Quality of live as assessed by EQ-5D questionnaire und ECOG performance status.;Timepoint(s) of evaluation of this end point: 6 weeks, 3 months and 6 months after brachytherapy.