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

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

NCT ID: NCT06018142

Condition: Neoplasms, Liver
Neoplasms Malignant
Neoplasm Metastasis
Ultrasound
Microvessels

Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Liver Neoplasms

Conditions: Keywords:
super-resolution ultrasound imaging
ultrasound
solid tumor
micro flow imaging
Microvessels

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Interventional Ultrasound of Chinese PLAGH

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Chaonan Chen

Phone: +8613693315104
Email: chenchaonan130@163.com

Contact backup:
Last name: Qianqian Zeng

Phone: +8617677573551
Email: tsengqianqian@qq.com

Start date: June 1, 2022

Completion date: February 28, 2025

Lead sponsor:
Agency: Chinese PLA General Hospital
Agency class: Other

Source: Chinese PLA General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06018142