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

NCT ID: NCT06158217

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-29

Study Completion Date

2025-05-06

Brief Summary

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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

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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.

Conditions

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Invasive Breast Cancer Cavitation Perfusion

Keywords

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Contrast-enhanced ultrasound ultrasound combined with microbubbles Invasive ductal carcinoma of breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ultrasound combined with microbubbles

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

Intervention Type PROCEDURE

Other Intervention Names

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Cavitation effect Microbubble assisted ultrasound technique

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunyun Dong, MS

Role: CONTACT

Phone: 01063138576

Email: [email protected]

Facility Contacts

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Yunyun Dong

Role: primary

Other Identifiers

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MR-11-22-009539

Identifier Type: -

Identifier Source: org_study_id