Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Status:
Completed
Trial end date:
2019-04-04
Target enrollment:
Participant gender:
Summary
This study is an exploratory study aiming to collect data about diagnosis efficacy
(sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with
suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC
confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology
analysis. The standard of reference for diagnosis will be given by the site according to
their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous
contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site
and/or the more recent AFP results available). 10 additional subjects will be included to
explore the diagnostic efficacy for HCC at half dose of P03277.