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The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | One arm diagnostic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene blue | Drug | 1 mC1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | intraoperatively; up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Allergic Reaction to Blue Dye) | number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension | intraoperatively up to 6 hours |
| Superficial Skin Necrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene A Woltering, MD | LSU Health Sciences Center - New Orleans LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Lafayette | Louisiana | 70506 | United States | ||
| LSU Interim Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | Posted | Number | participants | intraoperatively; up to 6 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| superficial skin necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eugene Woltering | LSU Dept of Surgery | 504 464-8500 | ewolte@lsuhsc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
| 2 weeks postoperatively |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Safety (Allergic Reaction to Blue Dye) | number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension | Posted | Number | participants | intraoperatively up to 6 hours |
|
|
|
| Secondary | Superficial Skin Necrosis | the number of participants who developed post-operative skin necrosis within 2 weeks of surgery | Posted | Dec 2011 | Number | participants | 2 weeks postoperatively |
|
|
|
| 0 |
| 62 |
| 2 |
| 62 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |