Axillary Reverse Mapping for Invasive Carcinoma of the Breast
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 25, 2008 | |||
| Last Updated Date | August 1, 2012 | |||
| Start Date ICMJE | March 2008 | |||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy [ Time Frame: 2 years for overall study ] [ Designated as safety issue: No ] Axillary reverse mapping (ARM) performed using 2 - 5cc of isosulfan blue, injected into the inner arm prior to skin incision for the axillary lymph node dissection. Blue channels identified during surgery and locations compared to axillary vein. Any blue nodes within the standard axillary lymph node dissection field removed then sent to pathology as a separate specimen labeled "axillary reverse mapping nodes" and evaluated with serial sectioning, and hematoxylin-eosin stain (H&E) as well as immunohistochemistry. |
|||
| Original Primary Outcome Measures ICMJE |
The goal of this clinical research study is to learn if axillary reverse mapping can find lymph nodes that are draining the arm. [ Time Frame: 30 Months ] [ Designated as safety issue: No ] | |||
| Change History | Complete list of historical versions of study NCT00645541 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM [ Time Frame: 2 years ] [ Designated as safety issue: No ] | |||
| Original Secondary Outcome Measures ICMJE |
The relationship between breast cancer and any draining lymph nodes found will also be studied. [ Time Frame: 30 Months ] [ Designated as safety issue: No ] | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Axillary Reverse Mapping for Invasive Carcinoma of the Breast | |||
| Official Title ICMJE | Axillary Reverse Mapping for Invasive Carcinoma of the Breast | |||
| Brief Summary | Primary Objectives:
|
|||
| Detailed Description | Lymphazurin is a blue dye used usually in breast cancer surgery to trace the drainage pathway that flows to lymph nodes. The dye will travel to the lymph system and will end up in the lymph nodes that are draining the arm. In this study, lymphazurin will be used to find the drainage routes from your arm, rather than your breast. AXILLARY REVERSE MAPPING: Before axillary lymph node surgery, your surgeon will inject lymphazurin into your arm. Your surgeon will watch how the dye flows and find the channels and nodes draining the arm. You will then have standard axillary lymph node (lymph nodes found under the arm) surgery. Any lymph nodes found that are dyed blue (lymph nodes that have traveled down the drainage pathways) that would normally be removed will be removed and sent to the pathology department. Pathologists will check the nodes to see if they have breast cancer cells in them. Also as part of routine care, all other axillary lymph nodes draining the breast will be removed and checked for breast cancer cells. This is an investigational study. Lymphazurin is FDA approved and commercially available. The use of lymphazurin with axillary reverse mapping is investigational. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson. |
|||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
|||
| Condition ICMJE | Breast Cancer | |||
| Intervention ICMJE | Procedure: Axillary Reverse Mapping
Lymphazurin, isosulfan blue dye, injected into arm then a standard axillary lymph node surgery to remove any blue dyed lymph nodes found (lymph nodes that have traveled down the drainage pathways). |
|||
| Study Arm (s) | Experimental: Axillary Reverse Mapping (ARM)
Intervention: Procedure: Axillary Reverse Mapping |
|||
| Publications * | Not Provided | |||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 35 | |||
| Completion Date | November 2010 | |||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
| Gender | Both | |||
| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00645541 | |||
| Other Study ID Numbers ICMJE | 2007-0951 | |||
| Has Data Monitoring Committee | No | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | M.D. Anderson Cancer Center | |||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
|
|||
| Information Provided By | M.D. Anderson Cancer Center | |||
| Verification Date | August 2012 | |||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||