Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer

NCT06158217 — Unknown, 30 participants, Beijing Friendship Hospital

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Registry	NCT06158217
Status	Unknown
Study type	Observational
Enrollment	30 (Estimated)
Sponsor	Beijing Friendship Hospital (Other)
Conditions	Invasive Breast Cancer, Cavitation, Perfusion
Interventions	ultrasound combined with microbubbles (Procedure)
Dates	start 2022-09-29, primary completion 2025-05-06 (estimated), completion 2025-05-06 (estimated), first posted 2023-12-06, last updated 2023-12-06
Locations	1 site in China

-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 study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).

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+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.

+Arms and interventions

ultrasound combined with microbubbles (Procedure), also known as Cavitation effect, Microbubble assisted ultrasound technique: IBC tumors were treated with microbubbles (MBs) stimulated by ultrasound

+Outcome measures

Primary outcomes

changes in peak intensity (PI) [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) [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 [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Clinical diagnosis of Invasive Breast Cancer
* patients scheduled to undergo surgical resection
* maximum lesion diameter < 4 cm
* age over 18 years

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Beijing Friendship Hospital, Capital Medical University	Beijing	China	Recruiting

+Publications

Results publication: 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. PMID 41656585