Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450723
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2007-03-20
Brief Title:
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Thoracoscopic Internal Mammary Sentinel Node Biopsy
Status:
COMPLETED
Status Verified Date:
2016-12
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 thoracoscopic sentinel lymph node biopsy may help find breast cancer that has spread to lymph nodes between the breasts It may also help doctors plan the best treatment
PURPOSE This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer
PURPOSE This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer
Determine the safety feasibility and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients
Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients
OUTLINE Patients undergo standard axillary sentinel lymph node dissection during surgery ie lumpectomy or mastectomy Patients receive a radioactive tracer ie technetium Tc 99m sulfur colloid and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes IMSLN Identified axillary sentinel lymph nodes are dissected Identified IMSLNs are removed through the lumpectomymastectomy incision if accessible If they are not accessible patients undergo thorascopic IMSLN biopsy to remove the nodes
All removed sentinel lymph nodes axillary or internal mammary are examined for gross and microscopic carcinoma for future therapy planning
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer
Determine the safety feasibility and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients
Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients
OUTLINE Patients undergo standard axillary sentinel lymph node dissection during surgery ie lumpectomy or mastectomy Patients receive a radioactive tracer ie technetium Tc 99m sulfur colloid and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes IMSLN Identified axillary sentinel lymph nodes are dissected Identified IMSLNs are removed through the lumpectomymastectomy incision if accessible If they are not accessible patients undergo thorascopic IMSLN biopsy to remove the nodes
All removed sentinel lymph nodes axillary or internal mammary are examined for gross and microscopic carcinoma for future therapy planning
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| WIRB-20050911 | OTHER | Western Institutional Review Board | None |
| SCCC-2003161 | OTHER | None | None |