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

NCT02973516 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GDX-44-008
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Value Evaluation for HCC

  Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference

  One day procedure

Study Arms (1)

P03277 triphasic imaging

EXPERIMENTAL

P03277 will be administered in order to acquire triphasic liver imaging

Drug: P03277 at 0.1 mmol/kg; Drug: P03277 at 0.05 mmol/kg

Interventions

P03277 at 0.1 mmol/kg 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.

Also known as: gadopiclenol at 0.1 mmol/kg

P03277 triphasic imaging

P03277 at 0.05 mmol/kg 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.

Also known as: gadopiclenol at 0.05 mmol/kg

P03277 triphasic imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guerbet: lead

Study Sites (2)

CHU Angers

Angers, 49933, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

This study is an exploratory study with limited number of patients included. The number of nodules in each cohort is considerably different, therefore limiting the possibility of comparison between the cohorts. Gadopiclenol owns very high relaxivity, which prolonged the wash-out at portal or delayed phases in some cases, further clinical investigation with larger number of patients is needed to study behavior of gadopiclenol in liver imaging.

Results Point of Contact

• Title: Jing Hao, MD, Head of Global Medical Affairs and Clinical Development
• Organization: Guerbet

jing.hao@guerbet.com

+33 (0) 1 45 91 50 00

Study Officials

• Clinical Project Manager

  Guerbet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: December 1, 2016
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: October 26, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)