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Completed

NCT Number: NCT00245869

Ultrasound and 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metaplasia Neoplasms Neoplasms by Site Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-Enhanced Ultrasound

Procedure

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Oct 28, 2005
Registry last updated
Feb 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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