Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT01149304
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80
* If female, postmenopausal or surgically sterilized
* Liver metastases from colorectal carcinoma scheduled for a CT/MRI-guided single-fraction 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
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 Gd-EOB-DTPA, Enoxaparin, Ursodeoxycholic acid and/or Pentoxifylline
* Any prior irradiation therapy of the liver
* Close affiliation with the investigational site; e.g. a close relative of the investigator
* Severe coronary artery disease
* Autoimmune diseases
* Acute bacterial endocarditis
* Active major bleedings and high rish of uncontrolled haemorrhage
* Patients with severe or moderate renal impairment (GFR below 60 mL/min/1.73 m2 according to the MDRD or Cockroft-Gault formula, calculated from a creatinine value obtained within 1 week before each planned Primovist-enhanced MR examination)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01149304
Study Brief:
Protocol Section:
NCT01149304