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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018142
• Other study ID #: S2023-408-01
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2023
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 010-66937981
• Email: liangping301[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Department of Interventional Ultrasound of Chinese PLAGH	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion index	The product of the average speed of microbubbles in region of interest (ROI) and the ROI area	30 minutes
Primary	Vessel diameter	To describe the diameters of the tiniest blood vessels that can be explored	30 minutes
Primary	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
Primary	Vessel density ratio	The ratio of blood vessel density between the core and peripheral areas of the tumor	30 minutes
Primary	Mean flow velocity	The average velocity in the region of interest	30 minutes
Primary	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
Primary	Perfusion ratio	Perfusion ratio of tumor core to peripheral area	30 minutes