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

18 Years
Not Enrolling
Breast Tumors

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Trial Information

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

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.

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

Type of Study:


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: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.

Outcome Time Frame:

Inclusion period

Principal Investigator

François Tranquart, PR

Investigator Role:

Study Director

Investigator Affiliation:

Centre d'Innovation Technologique CHRU Tours


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2004

Completion Date:

May 2007

Related Keywords:

  • Breast Tumors
  • Contrast-enhanced Ultrasound Sonography
  • Ultrasound Contrast agents, microbubbles
  • Breast tumors
  • Breast Neoplasms