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NCT Number: NCT07677839

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Health

Sacramento, California, 95816, United States

Location status: Recruiting

Location contact

Ara Salibian, MD

PRINCIPAL_INVESTIGATOR

Shari Nichols

CONTACT

[email protected]

(916) 734-7289

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IC-Green

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:

  • 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

  1. Outer lymphatic vessel diameter

    Time frame: During ultra-high frequency ultrasound imaging

    Total diameter including wall and lumen

Secondary outcomes

  1. Vessel wall thickness

    Time frame: During ultra-high frequency ultrasound imaging

    Vessel thickness will be measured using the 70Mhz probe

  2. Degree of sclerosis

    Time frame: During ultra-high frequency ultrasound imaging

    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

  3. Number of lymphatic channels

    Time frame: During ultra-high frequency ultrasound imaging

    Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured

  4. Channel confluence points

    Time frame: During ultra-high frequency ultrasound imaging

    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.

  5. Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress.

    Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.

    Severity and frequency will be documented using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (specific for cancer patients).

  6. Incidence of injection site reactions

    Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.

    Including pain, swelling, redness, or infection at injection sites

  7. Duration of injection site reactions

    Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.

    Length of duration of any injection site reaction

  8. Required interventions (e.g., antibiotics) for injection site reactions

    Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.

    Any required intervention for an injection site reaction

  9. Quantification of the lymphatic channels identified/ visualized along linear ICG patterns

    Time frame: During ultra-high frequency ultrasound imaging

    Number of lymphatic channels visualized per ICG line

  10. Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction)

    Time frame: During ultra-high frequency ultrasound imaging

    Number of lymphatic channels on ultrasound that merge with each other or separate per ultrasound zone

  11. correlation of ICG lymphography patterns and patient demographics

    Time frame: During ultra-high frequency ultrasound imaging

    Including body mass index, handedness (left/right dominant hand), and comorbidities (e.g., diabetes, hypertension, other chronic illnesses)

Study contacts

Contact information is provided by the study sponsor or research team.

Sheri Nichols

CONTACT

[email protected]

(916) 734-7289

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer

Acronym: UHFUS

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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