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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05790590

Enrollment

176

Registered

2023-03-30

Start date

2023-05-30

Completion date

2025-06-30

Last updated

2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastasis to Liver

Keywords

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.

Interventions

DIAGNOSTIC_TESTDouble low dose CT

Simultaneous reduction of both radiation dose and contrast media dose

DIAGNOSTIC_TESTStandard dose CT

CT with standard radiation dose and contrast media dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

Primary ContactHyuna Jung

jha5375@snu.ac.kr82-2-2072-4177

Backup ContactJeong Hee Yoon, MD

cinamon1@snu.ac.kr82-2-2072-2293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026