Invasive Breast Cancer Clinical Trial
Official title:
Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
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).
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
China,
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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