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| ID | Type | Description | Link |
|---|---|---|---|
| SU-06122012-10130 | Other Identifier | Stanford University | |
| BRS0022 | Other Identifier | OnCore |
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The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.
It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISB and ICG | Experimental | The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started. (IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPY Elite Imaging | Device | A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) | Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; "GREEN"), a fluorescent label; or isosulfan blue (IS-BLUE; "BLUE"), a visual dye. Results are expressed as:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Wapnir | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ISB and IC-Green Dye | The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ISB and IC-Green Dye | The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) | Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent. | Posted | Count of Participants | Participants | 1 day |
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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 | ISB and IC-Green Dye | The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Irene Wapnir | Stanford University | 650-724-1953 | Wapnir@stanford.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| C025484 | iso-sulfan blue |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indocyanine Green | Drug | started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%. |
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| Isosulfan blue | Drug | 3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%. |
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| 99technetium-sulfur colloid radiolabel | Drug |
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| 1 day |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; "GREEN"), a fluorescent label; or isosulfan blue (IS-BLUE; "BLUE"), a visual dye. Results are expressed as:
| Posted | Number | participants | 1 day |
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| 0 |
| 23 |
| 0 |
| 23 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| HOT, BLUE, GREEN |
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| HOT, GREEN only, no BLUE |
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