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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA206754 | U.S. NIH Grant/Contract | View source | |
| UW22145 | Other Identifier | UW Madison | |
| SMPH/SURGERY/SURG ONC | Other Identifier | UW Madison | |
| Protocol Version 11/29/2022 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| OnLume Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov Imaging Platform, to perform sentinel lymph node biopsy.
Participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. Active participation will last through the post-operative visit.
In this study, the sentinel lymph node biopsy will be performed with radioactive tracer (technetium-99 sulfur colloid) and blue dye, which is standard of care. Decisions will be made during surgery about which lymph nodes to remove using information from the radioactive tracer and blue dye alone.
For this research, ICG fluorescence dye during participant's surgery will also be used. After anesthesia has started, the ICG fluorescence dye will be injected in the breast along at the edge of the areola in the same location as the radioactive tracer and blue dye injections. The breast and axilla will then be imaged with the Asimov Imaging Platform to look for the sentinel lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node (SLN) mapping | Experimental | SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLN mapping using technetium-99m +/- isosulfan blue dye | Drug | The isosulfan blue dye injection will be performed by the participating surgeon in the operating room; as per standard of care, injection will be subareolar. Incisions will be planned based on the technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level | The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed. | Day of operation |
| Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level | The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence. | Day of operation |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the ICG Mapping | Using the technetium-99as the gold standard, the study team will describe the number of lymph nodes that would have been missed (i.e. technetium-99 + but ICG- in removed SLN) or would have been excised unnecessarily (i.e. residual ICG-fluorescence in axilla but no residual technetium-99) if ICG-fluorescent imaging had guided the SLN. | Day of operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Neuman, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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Participants were recruited in April and May of 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Lymph Node (SLN) Mapping | SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging. SLN mapping using technetium-99m +/- isosulfan blue dye: The isosulfan blue dye injection will be performed by the participating surgeon in the operating room; as per standard of care, injection will be subareolar. Incisions will be planned based on the technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care. SLN mapping with ICG fluorescence using the Asimov Platform: 2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. After injection, gentle manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to incision. After incision is made (following standard of care procedures), the axilla will be visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph nodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Lymph Node (SLN) Mapping | SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level | The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed. | Posted | Number | percent concordance | Day of operation |
|
|
Through post-operative visit, up to 3 weeks
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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 (SLN) Mapping | SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging. SLN mapping using technetium-99m +/- isosulfan blue dye: The isosulfan blue dye injection will be performed by the participating surgeon in the operating room; as per standard of care, injection will be subareolar. Incisions will be planned based on the technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care. SLN mapping with ICG fluorescence using the Asimov Platform: 2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. After injection, gentle manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to incision. After incision is made (following standard of care procedures), the axilla will be visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph nodes. |
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Difficult to differentiate general staining of the tissue from the ICG versus true residual fluorescence in a lymph node.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Neuman, MD, MS, FACS | University of Wisconsin School of Medicine and Public Health | (608) 262-9060 | neuman@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2023 | Jul 3, 2024 | Prot_SAP_000.pdf |
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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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|
| SLN mapping with ICG fluorescence using the Asimov Platform | Device | 2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. After injection, gentle manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to incision. After incision is made (following standard of care procedures), the axilla will be visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph nodes. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level | The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence. | Posted | Number | percent concordance | Day of operation |
|
|
|
| Secondary | Accuracy of the ICG Mapping | Using the technetium-99as the gold standard, the study team will describe the number of lymph nodes that would have been missed (i.e. technetium-99 + but ICG- in removed SLN) or would have been excised unnecessarily (i.e. residual ICG-fluorescence in axilla but no residual technetium-99) if ICG-fluorescent imaging had guided the SLN. | unable to assess, see post-hoc measures for data available and limitations and caveats for relevant detail | Posted | Day of operation |
|
|
| Post-Hoc | Number of Participants With Residual Radioactivity | Posted | Count of Participants | Participants | Day of operation |
|
|
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| Post-Hoc | Number of Participants With Visible Fluorescence in the Axilla | Posted | Count of Participants | Participants | day of operation |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D017437 |
| Skin and Connective Tissue Diseases |