Recruiting

UHFUS Characterization of Normal Lymphatic Anatomy

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.

ClinicalTrials.gov IDNCT07677839

PhaseNA

Enrollment50

SponsorUniversity of California, Davis

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Interventions

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.
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)

Primary outcomes

Outer lymphatic vessel diameter (During ultra-high frequency ultrasound imaging)

Eligibility information

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 locations

University of California Davis Health, Sacramento, California 95816 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.