Breast Cancer, Lymphedema, Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOnLume Imaging System
for fluorescence-guided surgery with ICG dye
DRUGIndocyanine green
Indocyanine green is a cyanine dye used in medical diagnostics
Sponsors
National Institutes of Health (NIH)
OnLume Inc.
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection * Surgery at University of Wisconsin Hospital and Clinic
Exclusion criteria
* Pregnant or breast feeding * Unable to provide informed consent * Allergy to indocyanine green * Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System | up to 1 day (day of surgery) | This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping |
| Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System | up to 1 day (day of surgery) | This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal | Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG] | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at UW Hospital and Clinics from May 2022 to April 2023.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Axillary Surgery |
|---|---|
| Age, Customized 30 to 39 years old | 1 Participants |
| Age, Customized 40 to 49 years old | 0 Participants |
| Age, Customized 50 to 59 years old | 3 Participants |
| Age, Customized 60 to 69 years old | 1 Participants |
| Age, Customized 70 to 79 years old | 3 Participants |
| Age, Customized 80 to 89 years old | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 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 | 0 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 | 9 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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
Time frame: up to 1 day (day of surgery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Axillary Surgery | Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System | Lymphatics spared by blue dye | 1 Participants |
| Axillary Surgery | Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System | Lymphatics spared by ICG | 5 Participants |
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
Time frame: up to 1 day (day of surgery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Axillary Surgery | Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System | Visualized by ICG | 9 Participants |
| Axillary Surgery | Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System | Visualized by Blue Dye | 5 Participants |
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.
Time frame: Imaging data will be collected on the day of surgery (Day 1) - CNR will be measured up to five minutes post-injection of ICG]
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Axillary Surgery | Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal | 54.9 Maximum CNR Ratio |