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

Not Applicable

Recruiting

• Conditions: Metastasis to Liver; Colorectal Cancer
• Interventions: Diagnostic Test: Standard dose CT; Diagnostic Test: Double low dose CT

• Registration Number: NCT05790590
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Study Start: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose CT	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.
Double low dose CT	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Radiation dose	1 month after primary study completion	Dose-length product (mGy\*cm) is compared between the two arms.
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.
Contrast media (CM) dose	1 month after primary study completion	The amount of CM dose 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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of