MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment MedDRA version: 22.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 100000004848
Conditions
Interventions
Product Code: Mangoral
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: Mangoral
CAS Number: 13446-34-9
Current Sponsor code: Mangoral (CMC-001)
Other descriptive name: MAN
Sponsors
Ascelia Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients 18 years and older Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations Severe renal impairment such as: a. Chronic kidney disease [CKD] (estimated glomerular filtrationrate [eGFR] =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Patients with simple liver cysts only Any investigational drug or device within 6 weeks prior to the Baseline Visit. Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit. Patients severe hepatic impairment (according to Child-Pugh score C). Patients scheduled for surgery before last study visit. Patients with encephalopathy / neurodegenerative or acute neurological disorders. Patients with hemochromatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the diagnostic efficacy of Mangoral in liver MRI in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI. Lesion visualization will be determined by qualitative assessments of lesion border delineation and lesion contrast compared to background liver on 4-point scales for up to 15 lesions per patient. ;Secondary Objective: • To assess the diagnostic efficacy of Mangoral in liver MRI in terms of: - no. lesions detected by each MRI method; - visualization of detected focal liver lesions in Mangoral-enhanced MRI comp. to unenhanced MRI; - confidence in lesion detection and localization in each MRI method; - lesion dimensions... - quantitative assessments … signal intensity enhancement of liver, liver-to-lesion contrast, signal-to-noise ratio, contrast-to-noise ratio - up to 5 lesions/pat.; - no. of patients who had at least 1 new lesion identified on CMRI compared to unenhanced MRI • To assess a proportion of pat. having at least 1 malignant lesion identified on postmangoral images that was not identified on pre-mangoral images. • To evaluate the safety and tolerability of Mangoral; • To evaluate the pharmacokinetics of manganese after a single dose of Mangoral in a subgroup of pat. • To evaluate the impact of diagnostic performance of CMRI and Mangoral-enhanced MRI versus unenhanced MRI ...;Primary end point(s): The primary efficacy endpoint will be the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI. Efficacy will be assessed by testing the superiority of each of the 2 co-primary variables: •lesion border delineation (BD), and •lesion contrast compared to liver background (LC). ;Timepoint(s) of evaluation of this end point: Assessments will be done during central reading sessions. All unenhanced and Mangoral-enhanced MRI image sets will be evaluat | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of lesions detected by each MRI method: unenhanced MRI, Mangoral-enhanced MRI, and CMRI. - Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI - Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI - Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI - Lesion dimensions - Quantitative assessments - Change(s) in patients’ management based on diagnostic performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI. ;Timepoint(s) of evaluation of this end point: Assessments will be done during central reading sessions as described in E.5.1.1. Additionally on-site evaluation will be done by each site investigator (or on-site radiologist) at the respective study site and will include separate assessments of all unenhanced and Mangoral-enhanced images of each patient. Data of on-site assessments will be used for analysis of specific secondary efficacy variables. In addition, brain MRI images will be evaluated by the independent off-site radiologist. Offsite evaluations should be performed within 5 working days after the respective MRI examination. | — |
Countries
Argentina, Colombia, Germany, Italy, Mexico, Poland, Russian Federation, Sweden, Turkey, United States
Contacts
Public ContactMarie Källström
Ascelia Pharma AB
Outcome results
None listed