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

NCT ID: NCT02973516

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-04-04

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.

Conditions

Chronic Liver Disease; HepatoCellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

P03277 triphasic imaging

P03277 will be administered in order to acquire triphasic liver imaging

Group Type: EXPERIMENTAL

P03277 at 0.1 mmol/kg

Intervention Type: DRUG

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.

P03277 at 0.05 mmol/kg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

gadopiclenol at 0.1 mmol/kg; gadopiclenol at 0.05 mmol/kg

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Manager

Role: STUDY_DIRECTOR

Guerbet

Locations

CHU Angers

Angers, , France

Hôpital Beaujon

Clichy, , France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GDX-44-008

Identifier Type: -

Identifier Source: org_study_id