Trial Information
Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
Principal Investigator
François Tranquart, PR
Investigator Role:
Study Director
Investigator Affiliation:
Centre d'Innovation Technologique - CHRU Tours
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CT03-FD/COR
NCT ID:
NCT00245869
Start Date:
March 2004
Completion Date:
February 2007
Related Keywords:
- Breast Cancer
- Contrast-enhanced Ultrasound
- Ultrasound Contrast agents, microbubbles
- breast cancer
- chemotherapy
- vascularization
- Breast Neoplasms