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Clinical Trials/NCT00245869
NCT00245869
Completed
Not Applicable

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

University Hospital, Tours1 site in 1 country30 target enrollmentMarch 2004
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University Hospital, Tours
Enrollment
30
Locations
1
Primary Endpoint
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
February 2007
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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