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.

Inclusion Criteria:

• Subject presenting with liver cirrhosis or chronic liver disease as shown by previous liver biopsy or by combination of clinical, endoscopic, biological, ultrasound parameters, and elastography
• Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than or equal to 3 cm (long axis) previously identified and/or characterized through enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed for HCC or not

Exclusion Criteria:

• Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less than or equal to 3 cm
• Subject already treated for HCC by surgery or thermal ablation for which the resection or coagulation area is less than 2 cm from the new nodule(s)
• Subject previously treated by transarterial chemoembolization
• Subject with moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m2) based on measurement done or available within the 7 days before P03277 administration and assessed after any iodinated contrast agent administration, or with dialysis end stage renal disease (ESRD)

Analysis was performed for the Full Analysis Set (FAS). One patient from cohort 1 was not included in the FAS for not presenting any nodule at the time of inclusion.

Adverse events were recorded from informed consent signature up to 13 weeks after gadopiclenol administration

Post-injection adverse events are reported below.

This study is an exploratory study with limited number of patients included. The number of nodules in each cohort is considerably different, therefore limiting the possibility of comparison between the cohorts.

Gadopiclenol owns very high relaxivity, which prolonged the wash-out at portal or delayed phases in some cases, further clinical investigation with larger number of patients is needed to study behavior of gadopiclenol in liver imaging.