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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06437457
Other study ID # 2023-RE-117
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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