Clinical trial NCT06018142: Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors
Official title: Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms, Liver
Neoplasms Malignant
Neoplasm Metastasis
Ultrasound
Microvessels
Keywords: super-resolution ultrasound imaging
ultrasound
solid tumor
micro flow imaging
Microvessels
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Perfusion index
timeFrame: 30 minutes
measure: Vessel diameter
timeFrame: 30 minutes
measure: Vessel density
timeFrame: 30 minutes
measure: Vessel density ratio
timeFrame: 30 minutes
measure: Mean flow velocity
timeFrame: 30 minutes
measure: Distance metric
timeFrame: 30 minutes
measure: Perfusion ratio
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Interventional Ultrasound of Chinese PLAGH
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: