MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04652947
• Lead Sponsor: University Hospital, Angers

Brief Summary

Compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules less than 3 cm, using LIRADS criteria

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-07
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Status Verified: 2020-07
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who had all three MRI scans as part of the diagnosis of the same suspected CHC lesion(s)
• Reference diagnosis obtained for suspected CHC nodules by a diagnostic algorithm taking into account histology, imaging and follow-up

Exclusion Criteria

• Delay between first MRI and 3rd MRI greater than 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules	3 months	the evaluation criteria will be the classification of each nodule according to the LiRADS citeria