Comparison of an oral and an injectable contrast agent for Magnetic Resonance Imaging used for diagnosis of liver lesions in diagnosed cancer patients.

• Conditions: Focal Liver Lesions in Diagnosed Cancer Patients; MedDRA version: 14.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-005917-35-SE
• Lead Sponsor: CMC Contrast AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-19
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the diagnostic accuracy of focal liver lesion detection by MRI following administration of CMC-001 and diffusion weighted imaging (DWI) of the liver in diagnosed cancer patients. For comparative purposes, data from standard of care examination by MRI following administration of gadoxetic acid and DWI of the liver will be used.;Secondary Objective: to further evaluate the safety and tolerability of CMC 001 in diagnosed cancer patients.;Primary end point(s): to assess diagnostic accuracy of method performance;Timepoint(s) of evaluation of this end point: At second patient visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): safety and tolerability of CMC-001;Timepoint(s) of evaluation of this end point: At second patient visit.