Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis

Phase 2

Completed

• Conditions: HepatoCellular Carcinoma; Chronic Liver Disease
• Interventions: Drug: P03277 at 0.1 mmol/kg; Drug: P03277 at 0.05 mmol/kg

• Registration Number: NCT02973516
• Lead Sponsor: Guerbet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Study Start: 2016-12
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Disposition First Submitted: 2020-07-27
• Disposition First Submitted QC: 2020-07-29
• Disposition First Posted: 2020-08-03
• Results First Submitted: 2021-09-09
• Results First Submitted QC: 2021-09-09
• Status Verified: 2021-10
• Results First Posted: 2021-10-06
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P03277 triphasic imaging	P03277 at 0.05 mmol/kg	P03277 will be administered in order to acquire triphasic liver imaging
P03277 triphasic imaging	P03277 at 0.1 mmol/kg	P03277 will be administered in order to acquire triphasic liver imaging

Primary Outcome Measures

Name	Time	Method
Diagnostic Value Evaluation for HCC	One day procedure	Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference

Trial Locations

Locations (2)

CHU Angers; 🇫🇷 Angers, France

Hôpital Beaujon; 🇫🇷 Clichy, France