Focal Liver Lesions in Diagnosed Cancer Patients MedDRA version: 14.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Code: CMC-001
Pharmaceutical Form: Oral solution
INN or Proposed INN: Manganese chloride tetrahydrate
CAS Number: 13446-34-9
Current Sponsor code: CMC-001
Other descriptive name: Manganese (II
Sponsors
CMC Contrast AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety and tolerability of CMC-001;Timepoint(s) of evaluation of this end point: At second patient visit. | — |
Countries
Sweden
Contacts
Public ContactClinical Operations(Thomas Hansson)
TFS AB
Outcome results
None listed