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

Recruiting

• Conditions: Perfusion; Cavitation; Invasive Breast Cancer

• Registration Number: NCT06158217
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Study Start: 2022-09-29
• Status Verified: 2023-06
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-05-06
• Study Completion: 2025-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China