Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye | Experimental | Indocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green (ICG) solution injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Outer lymphatic vessel diameter | Total diameter including wall and lumen | During ultra-high frequency ultrasound imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Vessel wall thickness | Vessel thickness will be measured using the 70Mhz probe | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheri Nichols | Contact | (916) 734-7289 | slnichols@health.ucdavis.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Health | Recruiting | Sacramento | California | 95816 | United States |
Individual participant data will not be shared due to the inclusion of sensitive health information and standardized photographs that cannot be fully de-identified. Data will be used solely for this study in accordance with UC Davis IRB approval.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping
Not provided
Not provided
Not provided
Not provided
|
| Ultra-High Frequency Ultrasound | Device | 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) |
|
| 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 | 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. | 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). | From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge. |
| Incidence of injection site reactions | Including pain, swelling, redness, or infection at injection sites | 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 | 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 | 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 | 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 | 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) | During ultra-high frequency ultrasound imaging |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004364 | Pharmaceutical Preparations |