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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06158217
Other study ID # MR-11-22-009539
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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