UHFUS Characterization of Normal Lymphatic Anatomy

NCT07677839 | Recruiting DMC FDA Device

• 1 other identifier: 2287319-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Outer lymphatic vessel diameter

  Total diameter including wall and lumen

  During ultra-high frequency ultrasound imaging

Secondary Outcomes (11)

• Vessel wall thickness

  During ultra-high frequency ultrasound imaging

• Degree of sclerosis

  During ultra-high frequency ultrasound imaging

• Number of lymphatic channels

  During ultra-high frequency ultrasound imaging

• Channel confluence points

  During ultra-high frequency ultrasound imaging

• 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.

Study Arms (1)

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.

Procedure: Indocyanine green (ICG) solution injection; Device: Ultra-High Frequency Ultrasound

Interventions

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.

Also known as: IC-Green

Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye

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)

Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18+ at the time of consent.
• \. Confirmed breast cancer diagnosis
• \. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
• \. Provision of a signed and dated informed consent form.
• \. Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• \. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
• \. History of prior axillary nodal surgery
• \. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Health

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green; Solutions

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Preparations

Central Study Contacts

Sheri Nichols

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 1, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): September 1, 2036
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)