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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00243698
• Date of registration: 21/10/2005
• Prospective Registration: No
• Primary sponsor: University Hospital, Tours
• Public title: A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
• Scientific title: A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
• Date of first enrolment: May 2004
• Target sample size: 59
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00243698
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Catherine LABBE, MD
• Affiliation: CRLCC René Gauducheau 44805 ST HERBLAIN

• Name: François Tranquart, PR
• Affiliation: Centre d'Innovation Technologique CHRU Tours

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Tumors

Intervention(s)

Drug: SonoVue (sulphur hexafluoride microbubbles)

Primary Outcome(s)

From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements. [Time Frame: Inclusion period]

Secondary Outcome(s)

Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only) [Time Frame: inclusion period]

Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples [Time Frame: inclusion period]

Secondary ID(s)

CT03-FT/SEN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors