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Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension

Primary Purpose

HCC, Cirrhosis, Liver

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Liver CT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HCC focused on measuring CT

Eligibility Criteria

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

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver CT with dual arterial phase

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2019
Last Updated
March 16, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04195971
Brief Title
Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension
Official Title
Multiphasic Liver CT Scan Including Dual Arterial Phase Imaging in Patients With Liver Cirrhosis and Suspected Portal Hypertension: Evaluation of Acquisition of Appropriate Late Arterial Phase Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Cirrhosis, Liver
Keywords
CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver CT with dual arterial phase
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Liver CT
Intervention Description
Liver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase.
Primary Outcome Measure Information:
Title
Incidence of optimal late arterial phase acquisition
Description
incidences of optimal late arterial phase acquisition in 1st and 2nd acquisition of arterial phase in this protocol (dual arterial phase) CT.
Time Frame
1 months after study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension

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