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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm Metastasis; Ultrasound; Neoplasms Malignant; Neoplasms, Liver; Microvessels

Detailed Description

In this study, 7 indexes were obtained by ultrasonic acquisition. These 7 indicators are used to describe and evaluate the microvessels in the tumor, so as to achieve the early identification and diagnosis of the tumor, and to monitor the growth of the tumor for a long time and evaluate the treatment of the tumor. This is not available with other ultrasound devices.

Based on contrast-enhanced ultrasound, this technology can provide information of smaller blood vessels, which will certainly contribute to the early diagnosis and real-time evaluation of solid tumors during treatment, and play an important role in clinical application.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jie Yu, Doctor; Phone Number: 010-66937981; Email: liangping301@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Department of Interventional Ultrasound of Chinese PLAGH
    • Contact: Chaonan Chen; Phone Number: +8613693315104; Email: chenchaonan130@163.com
    • Contact: Qianqian Zeng; Phone Number: +8617677573551; Email: tsengqianqian@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. The subject is known to be allergic to any component of the contrast agent Sonovue;
2. Lesions were diffuse or borderless on contrast ultrasound;
3. Patients who underwent previous anti-angiogenesis and chemotherapy, or other local treatment of the tumor;
4. Poor image display or deep position in conventional ultrasound evaluation (<10 cm from skin),
5. The researchers determined that there were any other factors that were not suitable for inclusion or affected participants' participation in the study
6. Patients with severe heart disease or lung disease;
7. Patients who are pregnant, may be pregnant or breastfeeding;
8. No enhanced MRI or enhanced CT results can be obtained;
9. The investigator considers the subjects unfit to participate in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Ping Liang, Doctor, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): October 28, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; solid tumor; Microvessels; super-resolution ultrasound imaging; micro flow imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: S2023-408-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The reason we cannot provide individual participant data (IPD) is because the data we obtained from the super-resolution ultrasound images is not publicly available

Drug and device information, study documents

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