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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma (HCC); Liver Metastasis; Focal Nodular Hyperplasia; Hepatic Hemangioma; Intrahepatic Cholangiocellular Carcinoma
• Intervention / Treatment: Diagnostic test: Perform super-resolution ultrasound imaging on the study population

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Wenli Zhang, PhD; Phone Number: +86 18817583752; Email: zhangwl9287@163.com
• Study Contact Backup: Name: Jing He; Phone Number: +86 18244242460; Email: G174265@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Any gender, 18 years or older;

2. 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.

3. Need to have a contrast-enhanced ultrasound as part of routine care;
4. Willing to join this study and sign the informed consent after discussing it with the doctor.

Exclusion Criteria:

1. During the data collection process, if the participant is unable to cooperate fully, preventing the collection from being completed;
2. 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;
3. Previous puncture biopsy or other treatments for existing liver malignant tumors;
4. Patients with a history of allergy, allergic constitution, or severe intolerance to sulfur hexafluoride or other components of the ultrasound contrast agent;
5. Patients who refuse to participate in this study;
6. Any uncontrollable comorbidities that could limit the patient's adherence to the study requirements or affect their ability to sign the written informed consent;
7. Poor overall condition or inability to tolerate relevant examinations;
8. Participants whom the researcher deems unsuitable for inclusion in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation group; Patients newly diagnosed with benign or malignant liver tumors	Diagnostic test: Perform super-resolution ultrasound imaging on the study population; Perform super-resolution ultrasound imaging on the study population, record and calculate characteristic hemodynamic and morphological parameters, and analyze microvascular flow patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in treatment effectiveness between patient subgroups	Treatment effectiveness is assessed using two different methods depending on the treatment modality: Pathological assessment (for patients who undergo surgical resection): A. Pathological complete response (pCR): no viable tumor cells detected in the postoperative specimen; B. Major pathological response (MPR): ≥50% reduction in the proportion of viable tumor cells compared to the baseline pretreatment specimen; Imaging assessment based on mRECIST criteria (for patients who do not undergo surgery): A. Complete Response (CR): disappearance of any intratumoral arterial enhancement in all target lesions B. Partial Response (PR): ≥30% decrease in the sum of diameters of viable target lesion C. Progressive Disease (PD): ≥20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters recorded since treatment started D. Stable Disease (SD): insufficient decrease to qualify for PR, and insufficient increase to qualify for PD	From date of treatment initiation until the date of first documented pathological or imaging response assessment, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Investigators: Study Chair: Hui Liu, Professor, Eastern Hepatobiliary Surgery Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HCC; ICC; SRUS; LM
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Focal Nodular Hyperplasia
• Other Study ID Numbers: EHBHK Y2024-H027-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No