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

HepatoCellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973516
• Other study ID #: GDX-44-008
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: April 4, 2019

Study information

• Verified date: October 2021
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chronic Liver Disease
• HepatoCellular Carcinoma
• Liver Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Value Evaluation for HCC	Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference	One day procedure