UHFUS Characterization of Normal Lymphatic Anatomy
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Indocyanine green (ICG) solution injection
- Ultra-High Frequency Ultrasound
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov