Neoplasms, LiverNCT06018142
Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors
An observational study of Neoplasms, Liver and Neoplasms Malignant, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms, Liver, Neoplasms Malignant, Neoplasm Metastasis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 28 Feb 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age over 18 years old, gender unlimited;
- Patients with solid organ tumors with a maximum diameter > 1cm;
- No contraindications with contrast ultrasound agents;
- It can improve the pathological results of the tumor or the diagnostic results supported by other relevant imaging tests.
- Patients can understand the purpose of the examination, voluntarily participate and sign the informed consent.
Who cannot join
- The subject is known to be allergic to any component of the contrast agent Sonovue;
- Lesions were diffuse or borderless on contrast ultrasound;
- Patients who underwent previous anti-angiogenesis and chemotherapy, or other local treatment of the tumor;
- Poor image display or deep position in conventional ultrasound evaluation (<10 cm from skin),
- The researchers determined that there were any other factors that were not suitable for inclusion or affected participants' participation in the study
- Patients with severe heart disease or lung disease;
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- Patients who are pregnant, may be pregnant or breastfeeding;
- No enhanced MRI or enhanced CT results can be obtained;
- The investigator considers the subjects unfit to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Interventional Ultrasound of Chinese PLAGH
Beijing
Chaonan Chen, +8613693315104, chenchaonan130@163.com
Qianqian Zeng, +8617677573551, tsengqianqian@qq.com
About this study
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.
Read the 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.
- Keywords
- super-resolution ultrasound imaging, ultrasound, solid tumor, micro flow imaging, Microvessels
- Medical subject headings
- Liver Neoplasms, Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index
The product of the average speed of microbubbles in region of interest (ROI) and the ROI area
Measured: 30 minutes
Vessel diameter
To describe the diameters of the tiniest blood vessels that can be explored
Measured: 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
Measured: 30 minutes
Vessel density ratio
The ratio of blood vessel density between the core and peripheral areas of the tumor
Measured: 30 minutes
Mean flow velocity
The average velocity in the region of interest
Measured: 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
Measured: 30 minutes
Perfusion ratio
Perfusion ratio of tumor core to peripheral area
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jun 2022
- Primary completion28 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, LiverStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018142
- Sponsor's protocol ID
- S2023-408-01
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Liang M, Liu J, Wang H, An S, Chen C, Chu H, Zhu M, Su X, Liang P, Zong Y, Wan M. Ultrasound super-resolved hemodynamic estimation in microvessel using physics-informed neural networks and data assimilation. Comput Methods Programs Biomed. 2026 Feb 1;274:109136. doi: 10.1016/j.cmpb.2025.109136. Epub 2025 Oct 30.
PubMed 41202508Zeng 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.
PubMed 39636384
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors
- ClinicalTrials.gov ID
- NCT06018142
- Acronym / sponsor ID
- S2023-408-01
- Keywords
- super-resolution ultrasound imaging, ultrasound, solid tumor, micro flow imaging, Microvessels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age over 18 years old, gender unlimited;
- Patients with solid organ tumors with a maximum diameter > 1cm;
- No contraindications with contrast ultrasound agents;
- It can improve the pathological results of the tumor or the diagnostic results supported by other relevant imaging tests.
- Patients can understand the purpose of the examination, voluntarily participate and sign the informed consent.
Key exclusion criteria (9 listed)
- The subject is known to be allergic to any component of the contrast agent Sonovue;
- Lesions were diffuse or borderless on contrast ultrasound;
- Patients who underwent previous anti-angiogenesis and chemotherapy, or other local treatment of the tumor;
- Poor image display or deep position in conventional ultrasound evaluation (<10 cm from skin),
- The researchers determined that there were any other factors that were not suitable for inclusion or affected participants' participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion index
Time frame: 30 minutes
The product of the average speed of microbubbles in region of interest (ROI) and the ROI area
Vessel diameter
Time frame: 30 minutes
To describe the diameters of the tiniest blood vessels that can be explored
Vessel density
Time frame: 30 minutes
To describe the ratio of the number of blood vessels in the tumor to the cross-sectional area of the tumor
Vessel density ratio
Time frame: 30 minutes
The ratio of blood vessel density between the core and peripheral areas of the tumor
Mean flow velocity
Time frame: 30 minutes
The average velocity in the region of interest
Distance metric
Time frame: 30 minutes
The ratio of the total length of the curve path to the straight line distance from the beginning to the end of the curve
Perfusion ratio
Time frame: 30 minutes
Perfusion ratio of tumor core to peripheral area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 41202508Liang M, Liu J, Wang H, An S, Chen C, Chu H, Zhu M, Su X, Liang P, Zong Y, Wan M. Ultrasound super-resolved hemodynamic estimation in microvessel using physics-informed neural networks and data assimilation. Comput Methods Programs Biomed. 2026 Feb 1;274:109136. doi: 10.1016/j.cmpb.2025.109136. Epub 2025 Oct 30.
- Derived from this study: PubMed 39636384Zeng 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Liang, Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Liver and Neoplasms Malignant, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Doctor (010-66937981, liangping301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index (time frame: 30 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.