The study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen.
Sentinel Lymph node (SLN) detection
Ability of peri-areolar or peri-tumoral fluorescein to detect SLNs in patients with operable breast cancer.
Time frame: 36 months
Fluorescence detection
To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer.
Time frame: 36 months
Correlation between two radiation intensities
To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN ex-vivo gamma radiation intensity.
Time frame: 36 months
Correlation between intensity and metastasis
To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis.
Time frame: 36 months
Fluorescence detection after processing
To evaluate if fluorescein fluorescence can be detected in the SLN after fixation and histological processing.
Time frame: 36 months
Number of patients with adverse events
To evaluate the safety of peri-areolar or peri-tumoral fluorescein injections.
Time frame: 36 months
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