Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-03-01 @ 12:18 AM
Study NCT ID:
NCT02973516
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Sponsor:
Guerbet
Organization:
Study Overview
Official Title:
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: