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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00245869
First received: October 26, 2005
Last updated: February 19, 2007
Last verified: July 2006
  Purpose

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 Intervention
Breast Cancer
Procedure: Contrast-enhanced Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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

Estimated Enrollment: 30
Study Start Date: March 2004
Estimated Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245869

Locations
France
University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00245869     History of Changes
Other Study ID Numbers: CT03-FD/COR
Study First Received: October 26, 2005
Last Updated: February 19, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 27, 2014