NCT07677839 · University of California, Davis
UHFUS Characterization of Normal Lymphatic Anatomy
(UHFUS)
What this study is about
This is a forward-looking 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.
View original scientific 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.
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
Total diameter including wall and lumen
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Sacramento, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations