A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Breast Tumors

Treatments

Drug: SonoVue (sulphur hexafluoride microbubbles)

Study type

Interventional

Funder types

Other

Identifiers

NCT00243698

CT03-FT/SEN

Details and patient eligibility

About

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 agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.

SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.

Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.

Full 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 (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.

Enrollment

59 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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