Accuracy in Diagnosis of Focal Liver Lesions following Oral Administration of CMC-001 Combined with Diffusion Weighted Magnetic Resonance Imaging (MRI) of the Liver. An Open-Label, Non-Randomised, Single-Centre Pilot Study in Diagnosed Cancer Patients.

CMC Contrast AB0 个研究点开始时间: 2012年1月19日最近更新: 2012年10月16日

适应症

试验速览

暂无简介。

•The study will include male or female cancer patients with focal liver lesions, aged 18 years or older, who have performed a standard of care MRI examination of the liver with gadoxetic acid (Primovist) and DWI of the liver at least 7 days prior to inclusion (Visit 1).
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1) Known or suspected hypersensitivity or allergy to the IMP, or to chemically related products.
•2) Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the patient or the objectives of the study, as judged by the Investigator.
•3) Concurrent severe illness in the gastrointestinal tract like paralysis or malabsorption, or clinically manifested jaundice.
•4) Known or suspected clinically severe concurrent illness that might influence the renal function or the patient had undergone kidney, liver or bone marrow transplantation.
•5) Known liver cirrhosis, severely reduced liver function (Child-Pugh class C), icteric obstructive hepatobiliary disease or portosystemic shunt.
•6) Female patients currently pregnant or breast-feeding. Female patients of childbearing potential (i.e. female patients who have not been post-menopausal for more than one year or who have not undergone sterilisation) must have a negative urine pregnancy test.
•7) Contraindications to MR imaging (e.g. aneurysm clip, pacemaker, or severe claustrophobia).
•8) Uncompensated cardiac failure (cardiac failure New York Heart Association grade 4 [NYHA IV]).
•9) Ongoing treatment with tetracycline or doxycycline.
•10) Use of antidiarrhoea or antinausea drugs during the last 7 days preceding this study.

发起方