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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-0939 | Other Identifier | Institutional Review Board | |
| A539713 | Other Identifier | UW Madison | |
| SMPH/SURGERY/SURG ONC | Other Identifier | UW Madison | |
| Protocol Version 11/3/2022 | Other Identifier | UW Madison | |
| 2R44CA206754-02A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| OnLume Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.
Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk of arm lymphedema.
In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.
The standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axillary Surgery | Experimental | Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnLume Imaging System | Device | for fluorescence-guided surgery with ICG dye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System | This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping | up to 1 day (day of surgery) |
| Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System | This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping | up to 1 day (day of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal | A time curve of contrast-to-noise (CNR) ratio of lymphatic vessels to background tissue will be measured over the time frame of up to five minutes post-injection. The fluorescence signal intensity in both (1) the lymphatic vessels and in (2) the surrounding tissue will be measured in fluorescence arbitrary units. These two values will be aggregated to calculate and report the CNR, which is a unitless ratio. The maximum CNR will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather B Neuman, MD, MS, FACS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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Participants were enrolled at UW Hospital and Clinics from May 2022 to April 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Axillary Surgery | Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. OnLume Imaging System: for fluorescence-guided surgery with ICG dye Indocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Axillary Surgery | Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. OnLume Imaging System: for fluorescence-guided surgery with ICG dye Indocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics |
| 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, Customized | 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 | Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System | This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping | Posted | Count of Participants | Participants | up to 1 day (day of surgery) |
|
up to 1 day (day of surgery)
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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 | Axillary Surgery | Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification. OnLume Imaging System: for fluorescence-guided surgery with ICG dye Indocyanine green: Indocyanine green is a cyanine dye used in medical diagnostics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Neuman, MD, MS | University of Wisconsin School of Medicine and Public Health | (608) 262-2025 | 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 | Nov 3, 2022 | Nov 8, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2022 | Aug 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indocyanine green |
| Drug |
Indocyanine green is a cyanine dye used in medical diagnostics |
|
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| Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG] |
| 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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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System | This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping | Posted | Count of Participants | Participants | up to 1 day (day of surgery) |
|
|
|
| Secondary | Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal | A time curve of contrast-to-noise (CNR) ratio of lymphatic vessels to background tissue will be measured over the time frame of up to five minutes post-injection. The fluorescence signal intensity in both (1) the lymphatic vessels and in (2) the surrounding tissue will be measured in fluorescence arbitrary units. These two values will be aggregated to calculate and report the CNR, which is a unitless ratio. The maximum CNR will be reported. | Posted | Mean | Inter-Quartile Range | Maximum CNR Ratio | Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG] |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |