Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245869
Status:
COMPLETED
Last Update Posted:
2007-02-21
First Post:
2005-10-26
Brief Title:
Ultrasound and Chemotherapy of Breast Cancer Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise
This real-time noninvasive and feasible imaging technique allows us the investigators at University Hospital Tours to evaluate early vascular changes of breast tumors during treatment These vascular changes may precede long-term tumoral regression Imaging of primary breast lesions may be of value in the prediction of late treatment response
An ultrasound will be performed before the initiation and after the second and the last dose of chemotherapy
To investigate the changes occurring in the vascularization of tumors we will use an intravascular ultrasound contrast agent SonoVue sulphur hexafluoride microbubbles
This agent is a microbubbles preparation that is stable resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis
This real-time noninvasive and feasible imaging technique allows us the investigators at University Hospital Tours to evaluate early vascular changes of breast tumors during treatment These vascular changes may precede long-term tumoral regression Imaging of primary breast lesions may be of value in the prediction of late treatment response
An ultrasound will be performed before the initiation and after the second and the last dose of chemotherapy
To investigate the changes occurring in the vascularization of tumors we will use an intravascular ultrasound contrast agent SonoVue sulphur hexafluoride microbubbles
This agent is a microbubbles preparation that is stable resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis
Detailed Description:
The main objective of the study is to evaluate the early vascular changes of the tumor during neoadjuvant chemotherapy compared to the clinical or MRI or histological response
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