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Recruiting NCT07677839

UHFUS Characterization of Normal Lymphatic Anatomy

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indocyanine green (ICG) solution injection, Ultra-High Frequency Ultrasound.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

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 outcome measures

  • Outer lymphatic vessel diameter [Time frame: During ultra-high frequency ultrasound imaging]
Secondary outcome measures (11)
  • Vessel wall thickness [Time frame: During ultra-high frequency ultrasound imaging]
  • Degree of sclerosis [Time frame: During ultra-high frequency ultrasound imaging]
  • Number of lymphatic channels [Time frame: During ultra-high frequency ultrasound imaging]
  • Channel confluence points [Time frame: During ultra-high frequency ultrasound imaging]
  • 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.]
  • Incidence of injection site reactions [Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.]
  • Duration of injection site reactions [Time frame: 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 [Time frame: 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 [Time frame: During ultra-high frequency ultrasound imaging]
  • Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction) [Time frame: During ultra-high frequency ultrasound imaging]
  • correlation of ICG lymphography patterns and patient demographics [Time frame: During ultra-high frequency ultrasound imaging]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of California Davis Health — Sacramento

Identifiers

NCT: NCT07677839 · 2287319-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗