NCT04195971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

December 26, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

December 10, 2019

Last Update Submit

March 16, 2021

Conditions

Keywords

CT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Liver CT with dual arterial phase

EXPERIMENTAL
Diagnostic Test: Liver CT

Interventions

Liver CTDIAGNOSTIC_TEST

Liver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase.

Liver CT with dual arterial phase

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Relative or absolute contra-indication of contrast-enhanced CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 12, 2019

Study Start

December 26, 2019

Primary Completion

September 21, 2020

Study Completion

June 1, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations