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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245869
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : February 21, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Contrast-enhanced Ultrasound Not Applicable

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  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Study Start Date : March 2004
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245869

University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Study Director: François Tranquart, PR Centre d'Innovation Technologique - CHRU Tours
Principal Investigator: Catherine LABBE, MD CRLCC René Gauducheau 44805 ST HERBLAIN

Publications: Identifier: NCT00245869     History of Changes
Other Study ID Numbers: CT03-FD/COR
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: July 2006

Keywords provided by University Hospital, Tours:
Contrast-enhanced Ultrasound
Ultrasound Contrast agents, microbubbles
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases