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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00243698
First received: October 21, 2005
Last updated: November 21, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention
Breast Tumors
 Drug: SonoVue (sulphur hexafluoride microbubbles)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

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

Enrollment: 59
Study Start Date: May 2004
Study Completion Date: May 2007
Intervention Details:
    Drug: SonoVue (sulphur hexafluoride microbubbles)
    One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243698

Locations
France
University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: François Tranquart, PR Centre d'Innovation Technologique CHRU Tours
Principal Investigator: Catherine LABBE, MD CRLCC René Gauducheau 44805 ST HERBLAIN
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00243698     History of Changes
Other Study ID Numbers: CT03-FT/SEN
Study First Received: October 21, 2005
Last Updated: November 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Contrast-enhanced Ultrasound Sonography
Ultrasound Contrast agents, microbubbles
Breast tumors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013