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Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT

Primary Purpose

Metastasis to Liver, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Double low dose CT
Standard dose CT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastasis to Liver focused on measuring CT

Eligibility Criteria

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

Inclusion Criteria: colorectal cancer (CRC) patients on surveillance or monitoring for liver metastasis (of CRC) Exclusion Criteria: any relative or absolute contra-indication of CECT diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard dose CT

Double low dose CT

Arm Description

Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner.

Double low dose protocol CT using low radiation dose (120 kVp & 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.

Outcomes

Primary Outcome Measures

lesion conspicuity on portal venous phase
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms.

Secondary Outcome Measures

lesion conspicuity on arterial phase
qualitative analysis of lesion conspicuity on arterial phase on five-point scale (higher score indicates better conspicuity) Lesion conspicuity is compared between the two arms.
lesion detectability
lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained.
Radiation dose
Dose-length product (mGy*cm) is compared between the two arms.
Contrast media (CM) dose
The amount of CM dose is compared between the two arms.

Full Information

First Posted
March 17, 2023
Last Updated
June 1, 2023
Sponsor
Seoul National University Hospital
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05790590
Brief Title
Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT
Official Title
Comparison of Image Quality Between "Double Low Dose" Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

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

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
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis to Liver, Colorectal Cancer
Keywords
CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard dose CT
Arm Type
Active Comparator
Arm Description
Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner.
Arm Title
Double low dose CT
Arm Type
Experimental
Arm Description
Double low dose protocol CT using low radiation dose (120 kVp & 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.
Intervention Type
Diagnostic Test
Intervention Name(s)
Double low dose CT
Intervention Description
Simultaneous reduction of both radiation dose and contrast media dose
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard dose CT
Intervention Description
CT with standard radiation dose and contrast media dose
Primary Outcome Measure Information:
Title
lesion conspicuity on portal venous phase
Description
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms.
Time Frame
6 months after primary study completion.
Secondary Outcome Measure Information:
Title
lesion conspicuity on arterial phase
Description
qualitative analysis of lesion conspicuity on arterial phase on five-point scale (higher score indicates better conspicuity) Lesion conspicuity is compared between the two arms.
Time Frame
6 months after primary study completion.
Title
lesion detectability
Description
lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained.
Time Frame
12 months after primary study completion.
Title
Radiation dose
Description
Dose-length product (mGy*cm) is compared between the two arms.
Time Frame
1 month after primary study completion
Title
Contrast media (CM) dose
Description
The amount of CM dose is compared between the two arms.
Time Frame
1 month after primary study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: colorectal cancer (CRC) patients on surveillance or monitoring for liver metastasis (of CRC) Exclusion Criteria: any relative or absolute contra-indication of CECT diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyuna Jung
Phone
82-2-2072-4177
Email
jha5375@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Hee Yoon, MD
Phone
82-2-2072-2293
Email
cinamon1@snu.ac.kr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuna Jung, RN
Phone
82-2-2072-4177
Email
jha5375@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT

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