This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics. The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
0.1cc of 2.5 mg/cc Indocyanine green (ICG) solution will be injected intradermally at the 1st and 4th webspaces of the hand, and radial and ulnar volar wrist areas.
UHFUS will capture still images at specific landmarks along the wrist-to-elbow axis to characterize lymphatic channels. The following quantitative data of lymphatic channels will be captured: 1\. Outer diameter (i.e., total diameter including wall and lumen); 2. Inner diameter (i.e., diameter of the lumen only); and 3. Wall thickness (i.e., the thickness of the lymphatic channel wall)
University of California Davis Health
Sacramento, California, United States
RECRUITINGOuter lymphatic vessel diameter
Total diameter including wall and lumen
Time frame: During ultra-high frequency ultrasound imaging
Vessel wall thickness
Vessel thickness will be measured using the 70Mhz probe
Time frame: During ultra-high frequency ultrasound imaging
Degree of sclerosis
Degree of sclerosis will be measured according to Bianchi et al (PMID: 32591265) as a Type I (ectatic, no wall sclerosis on ultrasound ) versus type (constricted, positive hyperechoic wall sclerosis on ultrasound) classification
Time frame: During ultra-high frequency ultrasound imaging
Number of lymphatic channels
Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured
Time frame: During ultra-high frequency ultrasound imaging
Channel confluence points
Confluence points will be categorized by the number of vessels that join in a signal ultrasound zone. This will first be a binary Yes or No outcome. If yes, then they will be categorized 2:1 for two vessels joining to one or 3:1 for three vessels joining to one.
Time frame: During ultra-high frequency ultrasound imaging
Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress.
Severity and frequency will be documented using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (specific for cancer patients).
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
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Incidence of injection site reactions
Including pain, swelling, redness, or infection at injection sites
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Duration of injection site reactions
Length of duration of any injection site reaction
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Required interventions (e.g., antibiotics) for injection site reactions
Any required intervention for an injection site reaction
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Quantification of the lymphatic channels identified/ visualized along linear ICG patterns
Number of lymphatic channels visualized per ICG line
Time frame: During ultra-high frequency ultrasound imaging
Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction)
Number of lymphatic channels on ultrasound that merge with each other or separate per ultrasound zone
Time frame: During ultra-high frequency ultrasound imaging
correlation of ICG lymphography patterns and patient demographics
Including body mass index, handedness (left/right dominant hand), and comorbidities (e.g., diabetes, hypertension, other chronic illnesses)
Time frame: During ultra-high frequency ultrasound imaging