Normal lymphatic anatomy in breast cancer patients using ultra-high frequency ultrasound and ICG
Official title: Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
Run by University of California, Davis · NCT07677839 · Data updated 2026-11-12
This study tests whether ultra-high frequency ultrasound plus indocyanine green dye can map normal lymphatic channels in breast cancer patients undergoing axillary procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | March 1, 2036 |
| Study ends | September 1, 2036 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07677839 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed breast cancer scheduled for ALND or SLNB who consent and are available for follow-up.
✕Probably not a fit
Patients with prior axillary surgery or known upper-extremity lymphatic/venous disease may not benefit from the imaging insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective pilot study enrolls adults with breast cancer who will have axillary lymph node dissection or sentinel lymph node biopsy. Participants receive indocyanine green dye and ultra-high frequency ultrasound to map lymphatic channels from the wrist to the elbow, aiming to characterize normal lymphatic anatomy. The study also examines ICG dye safety, variability in ultrasonographic lymphatic features, and how ICG pathways relate to UHFUS findings and patient demographics. Primary objective is to describe consistent ultrasonographic characteristics of normal lymphatics in this population. Secondary analyses explore correlations between imaging modalities and clinical factors.
Why it matters
Potential benefit: If successful, the findings could improve understanding of normal lymphatic anatomy in breast cancer patients and support future imaging-guided procedures.
How similar studies have gone: Prior studies using ICG with imaging techniques have shown useful mapping of lymphatics, but this exact UHFUS approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of California Davis Health
Sacramento, California, United States Recruiting
Study contacts
- Study coordinator: Sheri Nichols
- Email: slnichols@health.ucdavis.edu
- Phone: (916) 734-7289
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.