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

Primary Purpose

Chronic Liver Disease, HepatoCellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
P03277 at 0.1 mmol/kg
P03277 at 0.05 mmol/kg
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Angers
  • Hôpital Beaujon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

P03277 triphasic imaging

Arm Description

P03277 will be administered in order to acquire triphasic liver imaging

Outcomes

Primary Outcome Measures

Diagnostic Value Evaluation for HCC
Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference

Secondary Outcome Measures

Full Information

First Posted
November 22, 2016
Last Updated
October 6, 2021
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT02973516
Brief Title
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Official Title
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease, HepatoCellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P03277 triphasic imaging
Arm Type
Experimental
Arm Description
P03277 will be administered in order to acquire triphasic liver imaging
Intervention Type
Drug
Intervention Name(s)
P03277 at 0.1 mmol/kg
Other Intervention Name(s)
gadopiclenol at 0.1 mmol/kg
Intervention Description
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
Intervention Name(s)
P03277 at 0.05 mmol/kg
Other Intervention Name(s)
gadopiclenol at 0.05 mmol/kg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Value Evaluation for HCC
Description
Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference
Time Frame
One day procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Organizational Affiliation
Guerbet
Official's Role
Study Director
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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