Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00245869
• Lead Sponsor: University Hospital, Tours

Brief Summary

This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.

This real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.

An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.

To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).

This agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.

Detailed Description

The main objective of the study is to evaluate the early vascular changes of the tumor during neoadjuvant chemotherapy compared to the clinical or MRI or histological response.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Status Verified: 2006-07
• Study Completion: 2007-02
• Last Update Submitted: 2007-02-19
• Last Update Posted: 2007-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Breast tumor (size equal to or greater than 3 cm.). Patients with diagnosis of benign breast tumor based on biopsy will be excluded from the study after the first ultrasound examination.
• Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology.
• Performance status = 0, 1 or 2
• No previous surgery or local radiotherapy

Exclusion Criteria

• Psychiatric disorders
• Vital threat due to other disease
• Vital prognosis < 3 months
• Biopsy of the lesion performed within 1 month before the ultrasonography
• Patient known to have a coronary syndrome
• Unstable angina and myocardial infarction
• Acute cardiac failure, Class III/IV cardiac failure
• Several arrhythmias
• Acute endocarditis
• Prosthetic valves

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves

Trial Locations

Locations (1)

University Hospital of Tours; 🇫🇷 Tours, France