Invasive Breast CancerNCT06158217
Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
An observational study of Invasive Breast Cancer and Cavitation, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer, Cavitation, Perfusion
- What is being tested?
- ultrasound combined with microbubbles
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2022to 6 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Invasive breast cancer
Who may be able to join
- Clinical diagnosis of Invasive Breast Cancer
- patients scheduled to undergo surgical resection
- maximum lesion diameter < 4 cm
- age over 18 years
Who cannot join
- patients with allergies to SonoVue®
- patients with severe cardiopulmonary insufficiency,
- patients who had already received neoadjuvant chemotherapy
- pregnant women
- individuals with mental illness
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Yunyun Dong, 01063138576, 13811652027@163.com
About this study
Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).
Read the detailed description
patients with IBC were selected from the breast surgery department of our hospital. To induce an enhanced perfusion effect, IBC tumors were treated with SonoVue® microbubbles (MBs) stimulated by ultrasound, with a mechanical index (MI) of 0.2-0.3; 1 mL of SonoVue® MBs were injected at 3.5-min intervals three times for a USMB treatment lasting 10 min. The contrast-enhanced ultrasound (CEUS) parameters peak intensity (PI), area under the curve (AUC), and perfusion area were used to evaluate the changes in blood perfusion.
- Conditions
- Invasive Breast Cancer, Cavitation, Perfusion
- Being tested
- ultrasound combined with microbubbles
- Keywords
- Contrast-enhanced ultrasound, ultrasound combined with microbubbles, Invasive ductal carcinoma of breast
- Medical subject headings
- Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound combined with microbubblesProcedure or surgery
Also called Cavitation effect, Microbubble assisted ultrasound technique
IBC tumors were treated with microbubbles (MBs) stimulated by ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in peak intensity (PI)
PI represents the quantitative scale of the highest average concentration of microbubble (MB) in the region of interest (ROI); thus, a larger PI corresponds to a higher concentration of MB in the ROI.
Measured: 15 minutes after the USMB procedure
area under the curve (AUC)
AUC represents the total amount of MB passing through the ROI during perfusion; thus, a larger AUC corresponds to greater perfusion in the ROI.
Measured: 15 minutes after the USMB procedure
percentage increase in the perfusion area (%) of tumor
The percentage increase in the perfusion area (%) was calculated as follows: (perfusion area after the USMB procedure - perfusion area before the USMB procedure) × 100%/perfusion area before the USMB procedure. The greater "percentage increase of perfusion area (%)", the more significant the improvement of blood perfusion.
Measured: 15 minutes after the USMB procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start29 Sep 2022
- Primary completion6 May 2025 (estimated)
- Study completion6 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158217
- Sponsor's protocol ID
- MR-11-22-009539
- Status last verified
- Jun 2023
- First submitted
- 9 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dong Y, Zhang D, Feng W, Huang Y, Ge Z, Shi XQ. Effect of Ultrasound Combined with Microbubbles on Blood Perfusion in Invasive Breast Cancer-A Prospective Clinical Trial. Technol Cancer Res Treat. 2026 Jan-Dec;25:15330338261423051. doi: 10.1177/15330338261423051. Epub 2026 Feb 8.
PubMed 41656585
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT06158217
- Acronym / sponsor ID
- MR-11-22-009539
- Conditions
- Invasive Breast Cancer, Cavitation, Perfusion
- Keywords
- Contrast-enhanced ultrasound, ultrasound combined with microbubbles, Invasive ductal carcinoma of breast
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 6 May 2025 (estimated)
- Study completion
- 6 May 2025 (estimated)
- First posted
- 6 Dec 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.
Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).
Detailed description
patients with IBC were selected from the breast surgery department of our hospital. To induce an enhanced perfusion effect, IBC tumors were treated with SonoVue® microbubbles (MBs) stimulated by ultrasound, with a mechanical index (MI) of 0.2-0.3; 1 mL of SonoVue® MBs were injected at 3.5-min intervals three times for a USMB treatment lasting 10 min. The contrast-enhanced ultrasound (CEUS) parameters peak intensity (PI), area under the curve (AUC), and perfusion area were used to evaluate the changes in blood perfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Invasive breast cancer
Key inclusion criteria (4 listed)
- Clinical diagnosis of Invasive Breast Cancer
- patients scheduled to undergo surgical resection
- maximum lesion diameter < 4 cm
- age over 18 years
Key exclusion criteria (6 listed)
- patients with allergies to SonoVue®
- patients with severe cardiopulmonary insufficiency,
- patients who had already received neoadjuvant chemotherapy
- pregnant women
- individuals with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound combined with microbubblesAlso: Cavitation effect, Microbubble assisted ultrasound techniqueIBC tumors were treated with microbubbles (MBs) stimulated by ultrasound | Procedure or surgery | – |
Primary outcome
changes in peak intensity (PI)
Time frame: 15 minutes after the USMB procedure
PI represents the quantitative scale of the highest average concentration of microbubble (MB) in the region of interest (ROI); thus, a larger PI corresponds to a higher concentration of MB in the ROI.
area under the curve (AUC)
Time frame: 15 minutes after the USMB procedure
AUC represents the total amount of MB passing through the ROI during perfusion; thus, a larger AUC corresponds to greater perfusion in the ROI.
percentage increase in the perfusion area (%) of tumor
Time frame: 15 minutes after the USMB procedure
The percentage increase in the perfusion area (%) was calculated as follows: (perfusion area after the USMB procedure - perfusion area before the USMB procedure) × 100%/perfusion area before the USMB procedure. The greater "percentage increase of perfusion area (%)", the more significant the improvement of blood perfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 41656585Dong Y, Zhang D, Feng W, Huang Y, Ge Z, Shi XQ. Effect of Ultrasound Combined with Microbubbles on Blood Perfusion in Invasive Breast Cancer-A Prospective Clinical Trial. Technol Cancer Res Treat. 2026 Jan-Dec;25:15330338261423051. doi: 10.1177/15330338261423051. Epub 2026 Feb 8.
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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.
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 Invasive Breast Cancer and Cavitation, run by Beijing Friendship 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 4 inclusion and 6 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 6 Dec 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 Yunyun Dong, MS (01063138576, 13811652027@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in peak intensity (PI) (time frame: 15 minutes after the USMB procedure). The study lists 3 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 NCT06158217, which also lists 1 linked publication.
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 6 Dec 2023.