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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI diagnostic

Diagnostic Test

no intervention, patient only have MRI

Primary outcomes

compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules

Time frame: 3 months

the evaluation criteria will be the classification of each nodule according to the LiRADS citeria

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 3, 2020
Registry last updated: Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed