Comparison of Multiphase and Monophasic Arterial Hepatic... | NCT04687280

Studies
Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules

NCT04687280

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Dec 29, 2020Actual

Enrollment

153Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

non interventional

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2009Actual

Primary Completion Date

Oct 27, 2017Actual

Completion Date

Dec 2018Actual

First Submitted Date

Nov 26, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2020

Last Update Posted Date

Dec 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase.

Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. The purpose of this study is to compare arterial enhancement sensibilities between multi and single phase sequences.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Name	Type	Description	Arm Group Labels	Other Names
non interventional	Other	non interventional, study on data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
arterial enhancement	significant arterial enhancement present in one of the three phases of multiphasic arterial time compared to all other arterial phases or single phase	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient included in CHIC study with histology of hepatocellular carcinoma

Exclusion Criteria:

nodules already treated by chimioembolization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient followed up for cirrhosis with discovery of a suspicious CHC nodule during imaging monitoring

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided