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

NCT ID: NCT06018142

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-02-28

Brief Summary

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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

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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.

Conditions

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Neoplasms, Liver Neoplasms Malignant Neoplasm Metastasis Ultrasound Microvessels

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Liang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Department of Interventional Ultrasound of Chinese PLAGH

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Yu, Doctor

Role: CONTACT

010-66937981

Facility Contacts

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Chaonan Chen

Role: primary

+8613693315104

Qianqian Zeng

Role: backup

+8617677573551

References

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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.

Reference Type DERIVED
PMID: 39636384 (View on PubMed)

Other Identifiers

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S2023-408-01

Identifier Type: -

Identifier Source: org_study_id

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