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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05790590

Collaborator

Bayer (Industry)

176

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastasis to Liver Colorectal Cancer	Diagnostic Test: Double low dose CT Diagnostic Test: Standard dose CT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard dose CT 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.	Diagnostic Test: Standard dose CT CT with standard radiation dose and contrast media dose
Experimental: Double low dose CT Double low dose protocol CT using low radiation dose (80-120 kVp using automatic kV control program) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.	Diagnostic Test: Double low dose CT Simultaneous reduction of both radiation dose and contrast media dose

Arm

Intervention/Treatment

Active Comparator: Standard dose CT

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.

Diagnostic Test: Standard dose CT

CT with standard radiation dose and contrast media dose

Experimental: Double low dose CT

Double low dose protocol CT using low radiation dose (80-120 kVp using automatic kV control program) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.

Diagnostic Test: Double low dose CT

Simultaneous reduction of both radiation dose and contrast media dose

Outcome Measures

Primary Outcome Measures

lesion conspicuity on portal venous phase [6 months after primary study completion.]
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 [6 months after primary study completion.]
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 [12 months after primary study completion.]
lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained.
Radiation dose [1 month after primary study completion]
Dose-length product (mGy*cm) is compared between the two arms.
Contrast media (CM) dose [1 month after primary study completion]
The amount of CM dose is compared between the two arms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

colorectal cancer (CRC) patients
on surveillance or monitoring for liver metastasis (of CRC)
body mass index < 30

Exclusion Criteria:

any relative or absolute contra-indication of CECT
body mass index = 30 or more
diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital
Bayer

Investigators

Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05790590

Other Study ID Numbers:

SNUH-2022-3274

First Posted:

Mar 30, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 4, 2023