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

NCT06437457 | Completed DMC

• 1 other identifier: 2023-RE-117
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CEUS

The patients who underwent CEUS before liver resection

Radiation: ceus

CE-MRI

The patients who underwent CE-MRI before liver resection

Radiation: ceus

Interventions

ceus RADIATION

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.

CE-MRI; CEUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who underwent liver resection from January 2019 to May 2024 were included.

You may qualify if:

• had no anti-HCC therapy before imaging examinations.
• at least had one examination of Gd-EOB-DTPA-enhanced MRI and CEUS 2 weeks before surgery and confirmed as one single HCC.
• If the patient had both imaging tests, the time interval between two examinations was less than 1 weeks.
• both radiological and pathological results recorded the maximum tumor diameter.

You may not qualify if:

• had anti-HCC therapy before imaging examinations.
• had no examination of Gd-EOB-DTPA-enhanced MRI or CEUS 2 weeks before surgery .
• had no radiological or pathological results recorded the maximum tumor diameter.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anhui Medical University

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 20, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)