Breast Cancer
Conditions
Keywords
Breast cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIndocyanine green (ICG) solution injection
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.
DEVICEUltra-High Frequency Ultrasound
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)
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Aged 18+ at the time of consent. * 2\. Confirmed breast cancer diagnosis * 3\. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment * 4\. Provision of a signed and dated informed consent form. * 5\. Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion criteria
* 1\. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15 * 2\. History of prior axillary nodal surgery * 3\. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outer lymphatic vessel diameter | During ultra-high frequency ultrasound imaging | Total diameter including wall and lumen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel wall thickness | During ultra-high frequency ultrasound imaging | Vessel thickness will be measured using the 70Mhz probe |
| Degree of sclerosis | During ultra-high frequency ultrasound imaging | 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 |
| Number of lymphatic channels | During ultra-high frequency ultrasound imaging | Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured |
| Channel confluence points | During ultra-high frequency ultrasound imaging | 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. |
| Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress. | From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge. | Severity and frequency will be documented using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (specific for cancer patients). |
| Incidence of injection site reactions | From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge. | Including pain, swelling, redness, or infection at injection sites |
| Duration of injection site reactions | From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge. | Length of duration of any injection site reaction |
| Required interventions (e.g., antibiotics) for injection site reactions | From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge. | Any required intervention for an injection site reaction |
| Quantification of the lymphatic channels identified/ visualized along linear ICG patterns | During ultra-high frequency ultrasound imaging | Number of lymphatic channels visualized per ICG line |
| Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction) | During ultra-high frequency ultrasound imaging | Number of lymphatic channels on ultrasound that merge with each other or separate per ultrasound zone |
| correlation of ICG lymphography patterns and patient demographics | During ultra-high frequency ultrasound imaging | Including body mass index, handedness (left/right dominant hand), and comorbidities (e.g., diabetes, hypertension, other chronic illnesses) |
Countries
United States
Contacts
CONTACTSheri Nichols
Outcome results
None listed