Comparison of Gd-EOB-DTPA-enhanced MRI and Contrast-enhanced Ultrasound for Measuring Tumor Size of Solitary Hepatocellular Carcinoma ≤ 5cm:A Retrospective Study

HCC - Hepatocellular Carcinoma Clinical Trial

Official title:

Comparison of CE-MRI and CEUS for Measuring Tumor Size of HCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437457
• Other study ID #: 2023-RE-117
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Knowing the tumor size before operation is of great significance to the choice of treatment methods of surgeons and the prognosis of patients. In this study, two commonly used imaging methods( CE-MRI/CEUS) were selected to measure and compare the tumor size before operation, in order to determine which measurement method is more accurate.

Description:

A total of 194 patients who met the inclusion criteria from January 2019 through May 2024 were included. Taken pathological results as the gold standard, Paired T-test and Bland-Altman analisis were conducted to assess the correlation and mean absolute error between the measured tumor sizes obtained from CE-MRI/CEUS and pathological results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: May 20, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. had no anti-HCC therapy before imaging examinations.

2. at least had one examination of Gd-EOB-DTPA-enhanced MRI and CEUS 2 weeks before surgery and confirmed as one single HCC.

3. If the patient had both imaging tests, the time interval between two examinations was less than 1 weeks.

4. both radiological and pathological results recorded the maximum tumor diameter.

Exclusion Criteria:

1. had anti-HCC therapy before imaging examinations.

2. had no examination of Gd-EOB-DTPA-enhanced MRI or CEUS 2 weeks before surgery .

3. had no radiological or pathological results recorded the maximum tumor diameter.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HCC - Hepatocellular Carcinoma

Intervention

Radiation:
• ceus
MRI was performed by using a superconducting magnet scanner operated at 3.0 T (GE discovery MR750w, USA) and the CEUS examination (Mindray, China), ultrasound was performed first in B-mode to identify the suspicious lesions and then switched to contrast mode prior to the injection of the contrast medium.

Locations

Country	Name	City	State
China	Anhui Provincial Hospital	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring HCC diameter	the performance of Gd-EOB-DTPA-enhanced MRI (CE-MRI) and Contrast-enhanced Ultrasound (CEUS) in measuring tumor size of solitary hepatocellular carcinoma (HCC) =5cm.	Jaunary 2019 - May 2024