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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Metastasis to Liver
• Intervention / Treatment: Diagnostic test: Standard dose CT; Diagnostic test: Double low dose CT

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyuna Jung; Phone Number: 82-2-2072-4177; Email: jha5375@snu.ac.kr
• Study Contact Backup: Name: Jeong Hee Yoon, MD; Phone Number: 82-2-2072-2293; Email: cinamon1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hyuna Jung, RN; Phone Number: 82-2-2072-4177; Email: jha5375@snu.ac.kr
    • Principal Investigator: Jeong Min Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 (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.	Diagnostic test: Double low dose CT; Simultaneous reduction of both radiation dose and contrast media dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after primary study completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after primary study completion.
Radiation dose	Dose-length product (mGy*cm) is compared between the two arms.	1 month after primary study completion
Contrast media (CM) dose	The amount of CM dose is compared between the two arms.	1 month after primary study completion
lesion detectability	lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained.	12 months after primary study completion.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Bayer
• Investigators: Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: CT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SNUH-2022-3274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No