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

NCT00243698 | Completed

• 1 other identifier: CT03-FT/SEN
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Tumors

Keywords

Contrast-enhanced Ultrasound Sonography; Ultrasound Contrast agents, microbubbles; Breast tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples

  inclusion period

• Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)

  inclusion period

Interventions

SonoVue (sulphur hexafluoride microbubbles) DRUG

One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (5)

• 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. doi: 10.1016/j.ejrad.2004.04.017.

  PMID: 15664287 BACKGROUND

• 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. doi: 10.2325/jbcs.12.45.

  PMID: 15657523 BACKGROUND

• Watermann D, Madjar H, Sauerbrei W, Hirt V, Prompeler 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.

  PMID: 15010893 BACKGROUND

• Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.

  PMID: 14658595 BACKGROUND

• 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. doi: 10.1148/radiology.189.1.8372225.

  PMID: 8372225 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• François Tranquart, PR

  Centre d'Innovation Technologique CHRU Tours

  STUDY DIRECTOR

• Catherine LABBE, MD

  CRLCC René Gauducheau 44805 ST HERBLAIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 24, 2005
• Study Start: May 1, 2004
• Study Completion: May 1, 2007
• Last Updated: November 22, 2007

Record last verified: 2007-11

Locations

FR (1)