Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052676
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-01-24
Brief Title:
Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
Sponsor:
Centre Paul Strauss
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
French Randomized Sentinel Node Multicentric Study
Status:
COMPLETED
Status Verified Date:
2007-09
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 It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Determine the optimal mode of injection peritumoral vs periareolar of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification
Determine the reduction of morbidity associated with breast cancer surgery in terms of local control and survival in patients undergoing sentinel lymph node identification with these drugs
Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid
Arm II Patients receive periareolar injections as in arm I Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection
Patients are followed for disease evolution
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued for this study within 2-25 years
Determine the optimal mode of injection peritumoral vs periareolar of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification
Determine the reduction of morbidity associated with breast cancer surgery in terms of local control and survival in patients undergoing sentinel lymph node identification with these drugs
Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid
Arm II Patients receive periareolar injections as in arm I Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection
Patients are followed for disease evolution
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued for this study within 2-25 years
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 |
|---|---|---|---|
| EU-20214 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000258612 | REGISTRY | None | None |