Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243698
Status:
COMPLETED
Last Update Posted:
2007-11-22
First Post:
2005-10-21
Brief Title:
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None