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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye 		Indocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels.
  • Procedure: Indocyanine 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.
    Other names:
    • IC-Green
  • Device: Ultra-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)

Recruiting Locations

University of California Davis Health
Sacramento, California 95816
Contact:
Shari Nichols
(916) 734-7289
slnichols@health.ucdavis.edu

More Details

Status
Recruiting
Sponsor
University of California, Davis

Study Contact

Sheri Nichols
(916) 734-7289
slnichols@health.ucdavis.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.