At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 41 enrolled

Drug / intervention

P03277 at 0.1 mmol/kg +1 moredrug

Likely dose

P03277 0.1 mmol/kg IV bolus at 2 mL/s or 0.05 mmol/kg IV bolus at 2 mL/sAI-extracted

Key inclusion· 2

✓Liver cirrhosis or chronic liver disease documented by liver biopsy or combination of clinical, endoscopic, biological, ultrasound, and elastography findings
✓1 to 3 untreated hepatic nodules ≤3 cm (long axis) previously identified/characterized on enhanced CT or MRI within 21 days before P03277 imaging

Key exclusion· 4

✕Hepatic nodule >3 cm in addition to nodule(s) ≤3 cm
✕Prior HCC treatment by surgery or thermal ablation with resection/coagulation area <2 cm from new nodule(s)
✕Previous transarterial chemoembolization (TACE)
✕Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m²) or dialysis-dependent end-stage renal disease (ESRD)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02973516

NCT02973516Phase 2Completed

Compare CT.gov

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

Guerbet·interventional·Posted Nov 25, 2016·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating P03277 at 0.1 mmol/kg and P03277 at 0.05 mmol/kg for Chronic Liver Disease and HepatoCellular Carcinoma. Completed, enrolled 41 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Liver Disease, HepatoCellular Carcinoma

CountriesFrance

Collaborators--

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedNov 2016

Enrollment StartDec 2016

Primary CompletionApr 2019

TodayJul 2026

First PostedNov 25, 2016

Enrollment StartDec 1, 2016

Primary CompletionApr 4, 2019

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 9.6 years ago

Interventions

P03277 at 0.1 mmol/kgdrug

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/kgdrug

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.