Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005821
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-06-02
Brief Title:
Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2003-03
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 Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease
PURPOSE Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer
PURPOSE Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer
OUTLINE Patients are stratified according to node status positive vs negative
Patients undergo lymphoscintigraphy which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection
Surgery is performed within 24 hours of lymphoscintigraphy Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node Surgery begins within 5 minutes of the patent blue V dye injection
All lymph nodes that stain blue or have a high radioactive count are removed The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection
Some patients may only receive patent blue V dye injected as a pilot study Sentinel lymph node biopsy and axillary dissection proceed as above
PROJECTED ACCRUAL A total of 150 patients 75 per stratum will be accrued for the main study plus another 50 patients for the pilot study
Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer
OUTLINE Patients are stratified according to node status positive vs negative
Patients undergo lymphoscintigraphy which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection
Surgery is performed within 24 hours of lymphoscintigraphy Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node Surgery begins within 5 minutes of the patent blue V dye injection
All lymph nodes that stain blue or have a high radioactive count are removed The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection
Some patients may only receive patent blue V dye injected as a pilot study Sentinel lymph node biopsy and axillary dissection proceed as above
PROJECTED ACCRUAL A total of 150 patients 75 per stratum will be accrued for the main study plus another 50 patients for the pilot study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RMNHS-1631 | None | None | None |
| EU-20006 | None | None | None |