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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790590
• Other study ID #: SNUH-2022-3274
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Hyuna Jung
• Phone: 82-2-2072-4177
• Email: jha5375[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastasis to Liver

Intervention

Diagnostic Test:
• Double low dose CT
Simultaneous reduction of both radiation dose and contrast media dose
• Standard dose CT
CT with standard radiation dose and contrast media dose

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Radiation dose	Dose-length product (mGy*cm) is compared between the two arms.	1 month after primary study completion
Secondary	Contrast media (CM) dose	The amount of CM dose is compared between the two arms.	1 month after primary study completion