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

NCT06158217 | Unknown DMC

• 1 other identifier: MR-11-22-009539
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Invasive Breast Cancer; Cavitation; Perfusion

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

ultrasound combined with microbubbles PROCEDURE

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

Also known as: Cavitation effect, Microbubble assisted ultrasound technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Invasive breast cancer

You may qualify if:

• Clinical diagnosis of Invasive Breast Cancer
• patients scheduled to undergo surgical resection
• maximum lesion diameter \< 4 cm
• age over 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Interventions

Microbubbles

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Yunyun Dong, MS

CONTACT

01063138576; 13811652027@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 6, 2023
• Study Start: September 29, 2022
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-06

Locations

CN (1)