Page 44 - Fluorescence-guided cancer surgery
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Chapter 3
METHODS
Patients
Breast cancer patients planning to undergo breast surgery were eligible for participation in the trial. Patients planned for either breast conserving surgery (BCS) or modi ed radical mastectomy (MRM) were included. Consent was performed at the department of Surgery. Exclusion criteria were pregnancy or lactation, and various contraindications to MB including the use of serotonin reuptake inhibitors, serotonin and noradrenalin reuptake inhibitors and/or tricyclic antidepressants, severe renal failure, a G6PD-de ciency or a known allergy to MB. All patients gave informed consent and were anonymized.
Clinical trial
This clinical trial was approved by the Medical Ethics Committee of the Leiden University Medical Center and was performed in accordance with the ethical standards of the Helsinki Declaration of 1975.
Patients were divided in 2 administration groups, which di ered with respect to the timing of MB administration. 12 patients per group were administered 1.0 mg/kg MB intravenously over 5 min either immediately before surgery, or 3 h before surgery. Distribution between groups was based on the logistics of the operating room time on a particular day. Patients scheduled to be rst on the day’s surgical program were administered MB immediately before surgery (early imaging). Patients scheduled later in the day were administered MB 3 h before surgery (delayed imaging).
The mini-FLARE imaging system was used to identify the uorescent signal during surgery and on post-resected specimens transferred to the Pathology department. During surgery, images were obtained from the surgical eld, resected specimen, and wound bed after resection. When uorescent signal was observed, the operating surgeon could decide whether to resect the uorescent tissue or not, based on clinical judgment of the tissue. The resected specimen was sliced at the pathology department, where images from the bisected tumor were obtained. When possible, snap frozen tissue was collected for uorescence microscopy images.
