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

February 19, 2007 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • University hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: François Tranquart, PR, Centre d'Innovation Technologique - CHRU Tours
  • Principal Investigator: Catherine LABBE, MD, CRLCC René Gauducheau 44805 ST HERBLAIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion

February 1, 2007

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

February 21, 2007

Last Update Submitted That Met QC Criteria

February 19, 2007

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT03-FD/COR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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