UHFUS Characterization of Normal Lymphatic Anatomy
Recruiting · NCT07677839 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Davis
View the official record on ClinicalTrials.gov →Interventions studied
Indocyanine green (ICG) solution injectionUltra-High Frequency Ultrasound
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of California Davis Health - Sacramento, California, United States