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

NCT00243698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2007-11-22

No results posted yet for this study

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

Interventions

DRUG

SonoVue (sulphur hexafluoride microbubbles)

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • François Tranquart, PR · Centre d'Innovation Technologique CHRU Tours

  • Catherine LABBE, MD · CRLCC René Gauducheau 44805 ST HERBLAIN

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2007-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00243698 on ClinicalTrials.gov