Application of Super-Resolution Ultrasound (SRUS) in Liver Tumor

NCT07707661 | Not Yet Recruiting

• 1 other identifier: EHBHK Y2024-H027-P001
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

The macroscopic vascular supply of liver tumors varies considerably according to histological subtype, lesion size, and disease stage. Current clinical imaging modalities primarily characterize liver tumors based on their macroscopic vascular perfusion patterns. Conventional color Doppler ultrasonography enables qualitative assessment of tumor vascularity, facilitates the differentiation of benign from malignant hepatic lesions, delineates the anatomical relationship between tumors and major intrahepatic vessels, and detects vascular invasion. Nevertheless, these macroscopic vascular characteristics arise from complex microvascular architectures, including vascular distribution patterns, microvessel density, vessel morphology and tortuosity, blood flow velocity, and flow direction. Despite the critical role of tumor microcirculation in tumor progression and therapeutic response, the heterogeneity of microvascular hemodynamics among different liver tumors remains inadequately characterized. The emergence of Super Resolution Ultrasound Imaging (SRUS) has markedly advanced ultrasound imaging by overcoming the acoustic diffraction limit, enabling visualization of microvessels with diameters as small as approximately 20 μm. Unlike conventional ultrasound techniques, SRUS preserves the inherent advantages of ultrasound, including deep tissue penetration and a large field of view, while achieving an approximately tenfold improvement in spatial resolution. This unique combination effectively bridges the long-standing gap between imaging depth and spatial resolution in vascular imaging. Furthermore, by localizing and tracking individual circulating microbubbles,SRUS enables quantitative assessment of microvascular blood flow velocity over a broad dynamic range without Doppler angle dependence. Consequently, super-resolution ultrasound imaging offers an unprecedented opportunity to characterize and compare the microvascular hemodynamic features of benign and malignant liver lesions, thereby improving the accuracy of preoperative differential diagnosis, tumor staging, therapeutic response assessment, and prognostic evaluation.

Conditions

Hepatocellular Carcinoma (HCC); Intrahepatic Cholangiocellular Carcinoma; Hepatic Hemangioma; Focal Nodular Hyperplasia; Liver Metastasis

Keywords

HCC; SRUS; ICC; LM

Outcome Measures

Primary Outcomes (1)

• Vascular parameters in different types of benign and malignant liver tumors

  Assessing the differences in vascular parameters between different types of benign and malignant liver tumors

  At the time of initial diagnostic imaging (baseline), with pathological confirmation from subsequent surgical resection or biopsy obtained during the same hospitalization period.

Secondary Outcomes (1)

• Differences in treatment effectiveness between patient subgroups

  From date of treatment initiation until the date of first documented pathological or imaging response assessment, assessed up to 12 months

Study Arms (1)

Observation group

Patients newly diagnosed with benign or malignant liver tumors

Diagnostic Test: Perform super-resolution ultrasound imaging on the study population

Interventions

Perform super-resolution ultrasound imaging on the study population DIAGNOSTIC_TEST

Perform super-resolution ultrasound imaging on the study population, record and calculate characteristic hemodynamic and morphological parameters, and analyze microvascular flow patterns.

Observation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver tumor patients treated in the outpatient and inpatient departments of the Third Affiliated Hospital of the Naval Medical University.

You may qualify if:

• Any gender, 18 years or older;
• People newly diagnosed with liver tumors, including:
• ① Hepatocellular carcinoma; ② Cholangiocarcinoma; ③ Liver metastases; ④ Liver hemangioma; ⑤ Focal nodular hyperplasia of the liver.
• Need to have a contrast-enhanced ultrasound as part of routine care;
• Willing to join this study and sign the informed consent after discussing it with the doctor.

You may not qualify if:

• During the data collection process, if the participant is unable to cooperate fully, preventing the collection from being completed;
• If the skin in the collection area is broken or scabbed, or if there's too much ascites in the abdominal cavity interfering with sound signal penetration, making data collection impossible;
• Previous puncture biopsy or other treatments for existing liver malignant tumors;
• Patients with a history of allergy, allergic constitution, or severe intolerance to sulfur hexafluoride or other components of the ultrasound contrast agent;
• Patients who refuse to participate in this study;
• Any uncontrollable comorbidities that could limit the patient's adherence to the study requirements or affect their ability to sign the written informed consent;
• Poor overall condition or inability to tolerate relevant examinations;

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Focal Nodular Hyperplasia

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

• Hui Liu, Professor

  Eastern Hepatobiliary Surgery Hospital

  STUDY CHAIR

Central Study Contacts

Wenli Zhang, PhD

CONTACT

+86 18817583752; zhangwl9287@163.com

Jing He

CONTACT

+86 18244242460; G174265@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07