Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003654
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
1999-11-01
Brief Title:
Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-02
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:
RATIONALE Diagnostic procedures such as blue dye or imaging to identify sentinel lymph nodes may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors
PURPOSE Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer
PURPOSE Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer
Detailed Description:
OBJECTIVES I Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer II Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women
OUTLINE Patients receive patent blue V dye injection peritumorally prior to surgery Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection Nonpalpable tumors receive a localized injection using stereotactic injection techniques Patients then undergo standard axillary level I and II lymph node dissection
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study within 1 year
OUTLINE Patients receive patent blue V dye injection peritumorally prior to surgery Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection Nonpalpable tumors receive a localized injection using stereotactic injection techniques Patients then undergo standard axillary level I and II lymph node dissection
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-98055 | None | None | None |
| FRE-FNCLCC-96008 | None | None | None |