EUCTR2011-005917-35-SEActive, not recruitingNot Applicable
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.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- CMC Contrast AB
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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