"Double Low-Dose" DECT for HCC Imaging

HCC Clinical Trial

Official title:

Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045445
• Other study ID #: SNUH-2016-2830
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: September 25, 2019

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC. patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 25, 2019
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• high risk of HCC (chronic hepatitis B or C, or LC of any cause)
• signed informed consent
• scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis

Exclusion Criteria:

• no risk factor for HCC
• history of iodine hypersensitivity
• renal dysfunction (Estimated GFR < 30mL/min/1.73m2) or on dialysis
• metformin medication within 48 hours
• any other contraindication of CE-CT
• BMI > or = 30

Related Conditions & MeSH terms

• HCC

Intervention

Diagnostic Test:
• Double Low-Dose protocol CT
Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner
• Standard protocol CT
standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Philips Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	contrast media iodine amount	contrast media iodine amount	1 month after CT
Other	adverse effect	any adverse effect related with contrast media	1 month after CT
Other	Enhancement degree	HU in aorta, portal vein and liver parenchyma on each phase of CT	12 months after CT
Primary	Lesion conspicuity	qualitative conspicuity assessment of focal liver lesion	12 months after CT
Secondary	image noise	qualitative analysis	12 months after CT
Secondary	beam hardening artifact	qualitative analysis	12 months after CT
Secondary	hepatic artery conspicuity	qualitative analysis	12 months after CT
Secondary	portal vein conspicuity	qualitative analysis	12 months after CT
Secondary	image texture (plasticity)	qualitative analysis	12 months after CT
Secondary	overall image quality	qualitative analysis	12 months after CT
Secondary	presence of hepatic artery anatomic variation	yes, no, indeterminate and if yes) describe the variation	12 months after CT
Secondary	sensitivity to detect HCC	according to LI-RADS	18 months after CT
Secondary	radiation dose	CTDIvol, DLP, and effective dose	1 month after CT