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

Invasive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158217
• Other study ID #: MR-11-22-009539
• Status: Recruiting
• Start date: September 29, 2022
• Est. completion date: May 6, 2025

Study information

• Verified date: June 2023
• Source: Beijing Friendship Hospital
• Contact: Yunyun Dong, MS
• Phone: 01063138576
• Email: 13811652027[@]163.com
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 6, 2025
• Est. primary completion date: May 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer
• Perfusion

Intervention

Procedure:
• ultrasound combined with microbubbles
IBC tumors were treated with microbubbles (MBs) stimulated by ultrasound

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes after the USMB procedure
Primary	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.	15 minutes after the USMB procedure
Primary	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.	15 minutes after the USMB procedure