UHFUS Characterization of Normal Lymphatic Anatomy (UHFUS)

Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Indocyanine green (ICG) solution injection; Device: Ultra-High Frequency Ultrasound

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheri Nichols; Phone Number: (916) 734-7289; Email: slnichols@health.ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • University of California Davis Health
      • Contact: Shari Nichols; Phone Number: (916) 734-7289; Email: slnichols@health.ucdavis.edu
      • Principal Investigator: Ara Salibian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outer lymphatic vessel diameter	Total diameter including wall and lumen	During ultra-high frequency ultrasound imaging

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): September 1, 2036

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Indoles; Solutions; Indocyanine Green
• Other Study ID Numbers: 2287319-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No