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

Breast Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243698
• Other study ID #: CT03-FT/SEN
• Status: Completed
• Phase: N/A
• First received: October 21, 2005
• Last updated: November 21, 2007
• Start date: May 2004
• Est. completion date: May 2007

Study information

• Verified date: November 2007
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumors

Intervention

Drug:
• SonoVue (sulphur hexafluoride microbubbles)
One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (5)

Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. — View Citation

Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. — View Citation

Martínez AM, Medina CJ, Bustos C, Hernández JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30. — View Citation

Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51. — View Citation

Watermann D, Madjar H, Sauerbrei W, Hirt V, Prömpeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.		Inclusion period
Secondary	Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples		inclusion period
Secondary	Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)		inclusion period