Dual Arterial Phase Liver CT in Patients With Suspected P... | NCT04195971

Studies
Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension

NCT04195971

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2021Actual

Enrollment

69Actual

Phase

Not Applicable

Conditions

HCC
Cirrhosis, Liver

Interventions

Liver CT

Countries

South Korea

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2019Actual

Primary Completion Date

Sep 21, 2020Actual

Completion Date

Jun 2022Estimated

First Submitted Date

Dec 10, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

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

Mar 16, 2021

Last Update Posted Date

Mar 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeong Min Lee, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. In patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. In this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of LAP acquisition than single arterial phase acquisition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver CT with dual arterial phase	Experimental		Diagnostic Test: Liver CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver CT	Diagnostic Test	Liver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase.	Liver CT with dual arterial phase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of optimal late arterial phase acquisition	incidences of optimal late arterial phase acquisition in 1st and 2nd acquisition of arterial phase in this protocol (dual arterial phase) CT.	1 months after study completion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 20 years
Liver cirrhosis diagnosed with characteristic imaging feature or histology
Presence of portal hypertension sign (splenomegaly and varices)
Scheduled for liver CT
And signed informed consent

Exclusion Criteria:

Relative or absolute contra-indication of contrast-enhanced CT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong Min Lee, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided