Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors

NCT06018142 | Unknown

• 1 other identifier: S2023-408-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It has well accepted that tumor angiogenesis present aberrant vascular architecture and functional abnormalities, which is associated with tumorigenesis, tumor propagation and progression. By locating, separating and tracking microbubbles, the recently introduced and upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit. However, the acquisition of structural and functional parameters of microcirculation in vivo for ULM is still confined by the compromise between the resolution and penetration depth. The relatively long acquisition time induced the difficulty of motion correction potentially, which hampers the preclinical to clinical application in organs with distinct tissue motion such as the liver. Therefore, we take the lead in studying human liver lesion microvasculature, which remains a challenge for noninvasive, quantitative and functional intravital imaging especially due to its deep-seated location and strong motion. We developed a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its feasibility of visualizing and quantifying microvasculature in human organs.

Conditions

Neoplasms, Liver; Neoplasms Malignant; Neoplasm Metastasis; Ultrasound; Microvessels

Keywords

super-resolution ultrasound imaging; ultrasound; solid tumor; micro flow imaging; Microvessels

Outcome Measures

Primary Outcomes (7)

• Perfusion index

  The product of the average speed of microbubbles in region of interest (ROI) and the ROI area

  30 minutes

• Vessel diameter

  To describe the diameters of the tiniest blood vessels that can be explored

  30 minutes

• Vessel density

  To describe the ratio of the number of blood vessels in the tumor to the cross-sectional area of the tumor

  30 minutes

• Vessel density ratio

  The ratio of blood vessel density between the core and peripheral areas of the tumor

  30 minutes

• Mean flow velocity

  The average velocity in the region of interest

  30 minutes

• Distance metric

  The ratio of the total length of the curve path to the straight line distance from the beginning to the end of the curve

  30 minutes

• Perfusion ratio

  Perfusion ratio of tumor core to peripheral area

  30 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for the inclusion criteria as well as the exclusion criteria are enrolled in this study to obtain their clinical information.

You may qualify if:

• Age over 18 years old, gender unlimited;
• Patients with solid organ tumors with a maximum diameter \> 1cm;
• No contraindications with contrast ultrasound agents;
• It can improve the pathological results of the tumor or the diagnostic results supported by other relevant imaging tests.
• Patients can understand the purpose of the examination, voluntarily participate and sign the informed consent.

You may not qualify if:

• The subject is known to be allergic to any component of the contrast agent Sonovue;
• Lesions were diffuse or borderless on contrast ultrasound;
• Patients who underwent previous anti-angiogenesis and chemotherapy, or other local treatment of the tumor;
• Poor image display or deep position in conventional ultrasound evaluation (\<10 cm from skin),
• Patients with severe heart disease or lung disease;
• Patients who are pregnant, may be pregnant or breastfeeding;
• No enhanced MRI or enhanced CT results can be obtained;
• The investigator considers the subjects unfit to participate in this study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Department of Interventional Ultrasound of Chinese PLAGH

Beijing, China

RECRUITING

Related Publications (2)

• Liang M, Liu J, Wang H, An S, Chen C, Chu H, Zhu M, Su X, Liang P, Zong Y, Wan M. Ultrasound super-resolved hemodynamic estimation in microvessel using physics-informed neural networks and data assimilation. Comput Methods Programs Biomed. 2026 Feb 1;274:109136. doi: 10.1016/j.cmpb.2025.109136. Epub 2025 Oct 30.

  PMID: 41202508 DERIVED

• Zeng QQ, An SZ, Chen CN, Wang Z, Liu JC, Wan MX, Zong YJ, Jian XH, Yu J, Liang P. Focal liver lesions: multiparametric microvasculature characterization via super-resolution ultrasound imaging. Eur Radiol Exp. 2024 Dec 5;8(1):138. doi: 10.1186/s41747-024-00540-3.

  PMID: 39636384 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

010-66937981; liangping301@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: June 1, 2022
• Primary Completion: October 28, 2024
• Study Completion: February 28, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)