Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06158217
Enrollment
30
Registered
2023-12-06
Start date
2022-09-29
Completion date
2025-05-06
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cavitation, Invasive Breast Cancer, Perfusion

Keywords

Contrast-enhanced ultrasound, ultrasound combined with microbubbles, Invasive ductal carcinoma of breast

Brief 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).

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.

Interventions

PROCEDUREultrasound combined with microbubbles

IBC tumors were treated with microbubbles (MBs) stimulated by ultrasound

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in peak intensity (PI)15 minutes after the USMB procedurePI 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 procedureAUC 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 tumor15 minutes after the USMB procedureThe 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.

Countries

China

Contacts

Primary ContactYunyun Dong, MS
13811652027@163.com01063138576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026