Trial Outcomes & Findings for ICG and SLN Mapping (NCT NCT05859971)

Last Updated: 2025-07-29

Results Overview

The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Day of operation

Results posted on

2025-07-29

Participant Flow

Participants were recruited in April and May of 2023.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ICG and SLN Mapping

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sentinel Lymph Node (SLN) Mapping n=10 Participants SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Age, Continuous	60.8 years n=5 Participants
Sex: Female, Male Female	10 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	10 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	1 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	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of operation

The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node (SLN) Mapping n=10 Participants SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level	100 percent concordance

PRIMARY outcome

Timeframe: Day of operation

The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence.

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node (SLN) Mapping n=10 Participants SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level	100 percent concordance

SECONDARY outcome

Timeframe: Day of operation

Population: unable to assess, see post-hoc measures for data available and limitations and caveats for relevant detail

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.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Day of operation

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node (SLN) Mapping n=10 Participants SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Number of Participants With Residual Radioactivity	10 Participants

POST_HOC outcome

Timeframe: day of operation

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node (SLN) Mapping n=10 Participants SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Number of Participants With Visible Fluorescence in the Axilla	8 Participants

Adverse Events

Sentinel Lymph Node (SLN) Mapping

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, FACS

University of Wisconsin School of Medicine and Public Health

Phone: (608) 262-9060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place