## Protocol Section
### Identification Module
**NCT ID:** NCT06437457

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

**Official Title:** Comparison of CE-MRI and CEUS for Measuring Tumor Size of HCC

#### Organization Study ID Info
**ID:** 2023-RE-117
#### Organization
**Class:** OTHER
**Full Name:** Anhui Medical University
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Anhui Medical University

#### Responsible Party

**Investigator Affiliation:** Anhui Medical University

**Investigator Full Name:** Kunyuan Jiang

**Investigator Title:** Anhui Medical University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- HCC - Hepatocellular Carcinoma

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 194

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients who underwent CEUS before liver resection

**Intervention Names:**

- Radiation: ceus

**Label:** CEUS

#### Arm Group 2

**Description:** The patients who underwent CE-MRI before liver resection

**Intervention Names:**

- Radiation: ceus

**Label:** CE-MRI

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CE-MRI

- CEUS

**Description:** 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.

**Name:** ceus

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** measuring HCC diameter

**Time Frame:** Jaunary 2019 - May 2024

### Eligibility Module

**Eligibility Criteria:** 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.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The patients who underwent liver resection from January 2019 to May 2024 were included.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hefei

**Country:** China

**Facility:** Anhui Provincial Hospital

**State:** Anhui

**Zip:** 230001

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Hepatocellular Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
