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

Beijing Friendship Hospital30 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Invasive Breast Cancer Cavitation Perfusion

Interventions

ultrasound combined with microbubblesPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 15 minutes after the USMB procedure

Central Contacts

Yunyun Dong, MS

CONTACT

01063138576 13811652027@163.com

Data from ClinicalTrials.gov

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