Trial Outcomes & Findings for Intraoperative Evaluation of Axillary Lymphatics (NCT NCT05094102)
NCT ID: NCT05094102
Last Updated: 2024-11-13
Results Overview
This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
up to 1 day (day of surgery)
Results posted on
2024-11-13
Participant Flow
Participants were enrolled at UW Hospital and Clinics from May 2022 to April 2023.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Evaluation of Axillary Lymphatics
Baseline characteristics by cohort
| Measure |
Axillary Surgery
n=9 Participants
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
|
|---|---|
|
Age, Customized
30 to 39 years old
|
1 Participants
n=5 Participants
|
|
Age, Customized
40 to 49 years old
|
0 Participants
n=5 Participants
|
|
Age, Customized
50 to 59 years old
|
3 Participants
n=5 Participants
|
|
Age, Customized
60 to 69 years old
|
1 Participants
n=5 Participants
|
|
Age, Customized
70 to 79 years old
|
3 Participants
n=5 Participants
|
|
Age, Customized
80 to 89 years old
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 day (day of surgery)This measure will determine whether lymphatics were visualized (yes/no) by each modality during axillary reverse mapping
Outcome measures
| Measure |
Axillary Surgery
n=9 Participants
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
|
|---|---|
|
Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System
Visualized by Blue Dye
|
5 Participants
|
|
Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System
Visualized by ICG
|
9 Participants
|
PRIMARY outcome
Timeframe: up to 1 day (day of surgery)This measure will determine whether lymphatics were spared (yes/no) by each modality during axillary reverse mapping
Outcome measures
| Measure |
Axillary Surgery
n=9 Participants
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
|
|---|---|
|
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
|
|
Number of Cases Where Lymphatics Were Spared by Blue Dye Versus by ICG Using the OnLume Imaging System
Lymphatics spared by ICG
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Axillary Surgery
n=9 Participants
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
|
|---|---|
|
Maximum Contrast-to-Noise Ratio of ICG/OnLume Imaging System Fluorescence Signal
|
54.9 Maximum CNR Ratio
Interval 16.7 to 35.0
|
Adverse Events
Axillary Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heather Neuman, MD, MS
University of Wisconsin School of Medicine and Public Health
Phone: (608) 262-2025
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place