Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005058
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-04-06
Brief Title:
Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Direct Comparison of Contrast Enhanced Power Doppler Ultrasound in Primary Breast Cancer and Axillary Nodal Status With Histopathological Variables and Clinical Outcome
Status:
UNKNOWN
Status Verified Date:
2005-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE New imaging procedures such as enhanced ultrasound may improve the ability to determine the extent of breast cancer
PURPOSE Diagnostic study of enhanced ultrasound in women who have locally advanced primary breast cancer
PURPOSE Diagnostic study of enhanced ultrasound in women who have locally advanced primary breast cancer
Detailed Description:
OBJECTIVES I Measure blood flow of primary breast lesions and corresponding lymph nodes by Power Doppler Ultrasound PDU and compare this information with metastatic potential and patient survival in women with primary breast cancer II Correlate intratumor-nodal blood flow with pathological variables using standard histology and special stains in this patient population III Correlate intratumor microvessel density with total tumor blood flow and with the presence of axillary lymph node metastases using this diagnostic method in these patients IV Correlate tumor blood flow with various markers of angiogenesis using this diagnostic method in these patients V Compare tumor blood flow as measured with PDU before and after contrast enhancement in these patients
OUTLINE This is a diagnostic study Patients receive ultrasound contrast agent IV An ultrasound probe with Power Doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement Blood flow data is acquired over the volume of the mass andor lymph nodes using a video recorder The scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes Within 1 week of the ultrasound patients undergo surgery and the mass and axillary lymph nodes are removed
PROJECTED ACCRUAL Approximately 200 patients will be accrued for this study within 1 year
OUTLINE This is a diagnostic study Patients receive ultrasound contrast agent IV An ultrasound probe with Power Doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement Blood flow data is acquired over the volume of the mass andor lymph nodes using a video recorder The scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes Within 1 week of the ultrasound patients undergo surgery and the mass and axillary lymph nodes are removed
PROJECTED ACCRUAL Approximately 200 patients will be accrued for this study within 1 year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20003 | None | None | None |
| RMNHS-1443 | None | None | None |