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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Indocyanine green (ICG) solution injection
Procedure/Surgery0.1cc 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.
Ultra-High Frequency Ultrasound
DeviceUHFUS 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)
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dyeExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Outer lymphatic vessel diameter
Total diameter including wall and lumen
Time frame
During ultra-high frequency ultrasound imagingSecondary outcomes
1
Vessel wall thickness
Vessel thickness will be measured using the 70Mhz probe
Time frame
During ultra-high frequency ultrasound imaging2
Degree of sclerosis
Degree of sclerosis will be measured according to Bianchi et al (PMID: 32591265) as a Type I (ectatic, no wall sclerosis on ultrasound ) versus type (constricted, positive hyperechoic wall sclerosis on ultrasound) classification
Time frame
During ultra-high frequency ultrasound imaging3
Number of lymphatic channels
Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured
Time frame
During ultra-high frequency ultrasound imaging4
Channel confluence points
Confluence points will be categorized by the number of vessels that join in a signal ultrasound zone. This will first be a binary Yes or No outcome. If yes, then they will be categorized 2:1 for two vessels joining to one or 3:1 for three vessels joining to one.
Time frame
During ultra-high frequency ultrasound imagingSponsors and contacts
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Source ClinicalTrials.gov