University of California Davis Health
Sacramento, California, 95816, United States
Location status: Recruiting
NCT Number: NCT07677839
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Sacramento, California, 95816, United States
Location status: Recruiting
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. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.
The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IC-Green
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:
Time frame: During ultra-high frequency ultrasound imaging
Total diameter including wall and lumen
Time frame: During ultra-high frequency ultrasound imaging
Vessel thickness will be measured using the 70Mhz probe
Time frame: During ultra-high frequency ultrasound imaging
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 imaging
Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured
Time frame: During ultra-high frequency ultrasound imaging
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: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Severity and frequency will be documented using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (specific for cancer patients).
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Including pain, swelling, redness, or infection at injection sites
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Length of duration of any injection site reaction
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Any required intervention for an injection site reaction
Time frame: During ultra-high frequency ultrasound imaging
Number of lymphatic channels visualized per ICG line
Time frame: During ultra-high frequency ultrasound imaging
Number of lymphatic channels on ultrasound that merge with each other or separate per ultrasound zone
Time frame: During ultra-high frequency ultrasound imaging
Including body mass index, handedness (left/right dominant hand), and comorbidities (e.g., diabetes, hypertension, other chronic illnesses)
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
Acronym: UHFUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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