Breast Cancer
Conditions
Keywords
breast cancer, sentinel lymph node, ICG fluorescence
Brief summary
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.
Detailed description
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.
Interventions
DRUGSLN 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.
DEVICESLN 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.
Sponsors
OnLume Inc.
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * Diagnosis of clinical T1 or T2 breast cancer clinically node negative breast cancer requiring surgical lymph node evaluation * Surgery at University of Wisconsin Hospital and Clinic
Exclusion criteria
* Pregnant: It is not known whether indocyanine green can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Women of child-bearing age will undergo a urine pregnancy test on the day of surgery, which is standard of care prior to anesthesia. * Breastfeeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when indocyanine green is administered to a nursing woman. Study team will exclude women who are breastfeeding. * Unable to provide informed consent * Allergy to indocyanine green * History of ipsilateral breast or axillary surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level | Day of operation | The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed. |
| Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level | Day of operation | The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the ICG Mapping | Day of operation | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in April and May of 2023.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Sentinel Lymph Node (SLN) Mapping |
|---|---|
| Age, Continuous | 60.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Day of operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node (SLN) Mapping | Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level | 100 percent concordance |
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.
Time frame: Day of operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node (SLN) Mapping | Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level | 100 percent concordance |
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.
Time frame: Day of operation
Population: unable to assess, see post-hoc measures for data available and limitations and caveats for relevant detail
Post Hoc
Number of Participants With Residual Radioactivity
Time frame: Day of operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sentinel Lymph Node (SLN) Mapping | Number of Participants With Residual Radioactivity | 10 Participants |
Post Hoc
Number of Participants With Visible Fluorescence in the Axilla
Time frame: day of operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sentinel Lymph Node (SLN) Mapping | Number of Participants With Visible Fluorescence in the Axilla | 8 Participants |