Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors

NCT06524557 | Recruiting DMC

• 1 other identifier: KY-20180101-3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To explore an effective noninvasive method for differential diagnosis of liver tumors.

Conditions

Liver Tumor

Keywords

liver tumors; benign; malignant; Differential diagnosis

Outcome Measures

Primary Outcomes (1)

• The differential diagnosis of liver tumors

  Multimodal ultrasound is of great value in the differential diagnosis of liver tumors

  2018.01-2025.12

Study Arms (2)

with chronic liver disease

patients with hepatitis B virus, hepatitis C virus and other chronic liver disease.

Diagnostic Test: with chronic liver disease

without chronic liver disease

patients without hepatitis B virus, hepatitis C virus and other chronic liver disease.

Interventions

with chronic liver disease DIAGNOSTIC_TEST

patients with hepatitis B virus，hepatitis C virus, or other chronic liver disease

with chronic liver disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.

You may qualify if:

• (1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.

You may not qualify if:

• (1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hosptial

Xi'an, Xi'an, 710032, China

RECRUITING

Related Publications (1)

• Zhou H, Sang L, Sun Y, Gong X, Zhang J, Liu L, Wei J, Jiao W, Yu M. Performance of Ultrasonography-Based Fractal Parameters in Distinguishing Hepatocellular Carcinoma From Intrahepatic Cholangiocarcinoma. Ultrason Imaging. 2025 Jul;47(3-4):115-124. doi: 10.1177/01617346251330257. Epub 2025 Apr 15.

  PMID: 40231713 DERIVED

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 Officials

• Zhou Huihui, M.M.

  Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University

  STUDY CHAIR

Central Study Contacts

Zhou Huihui, M.M.

CONTACT

15209239680; huihui2807201830@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: January 1, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)