Mangoral for Focal Liver Lesions and Severe Renal Impairment

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Focal Liver Lesions and Severe Renal ImpairmentMangoral - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new MRI contrast agent for people with kidney problems and possible liver lesions. The goal is to see if the agent is safe and can help doctors better see the lesions.

Eligible Conditions
  • Focal Liver Lesions and Severe Renal Impairment

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1 year

1 year
Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. 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: longest diameter of largest and smallest lesion
Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.)
Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio)
The primary efficacy endpoint is the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI.
Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Mangoral
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Mangoral · No Placebo Group · Phase 3

Mangoral
Drug
Experimental Group · 1 Intervention: Mangoral · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Ascelia Pharma ABLead Sponsor
Bernd Hamm, MDPrincipal InvestigatorCharite Berlin, Dept. of Radiology

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have focal liver lesions based on medical history and previous laboratory and/or imaging examinations.