NCT02973516

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

Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease
• HepatoCellular Carcinoma

Interventions

Type	Name	Description
DRUG	P03277 at 0.1 mmol/kg	P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
DRUG	P03277 at 0.05 mmol/kg	P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-04-04
• Completion: 2019-04-04
• First posted: 2016-11-25
• Last updated: 2021-10-26
• Results posted: 2021-10-06

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study