Status:
COMPLETED
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Lead Sponsor:
University Hospital, Tours
Conditions:
Breast Tumors
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Ultrasound is a well-established imaging modality for the evaluation of breast disease. The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast ag...
Detailed Description
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (e...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
- Woman scheduled for biopsy or surgery within 1 month from the examination.
Exclusion
- Patients who have already performed a biopsy on the lesion during investigation
- Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
- Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
- Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
- Pregnant or nursing female
- Patient known to have a coronary syndrome
- Unstable angina and myocardial infarction
- Acute cardiac failure, Class III/IV cardiac failure
- Severe rhythm disorders
- Acute endocarditis
- Prosthetic valves
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00243698
Start Date
May 1 2004
End Date
May 1 2007
Last Update
November 22 2007
Active Locations (1)
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1
University Hospital of Tours
Tours, France, 37044