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Imaging based on the EPR e ect in ovarian cancer 117
MATERIAL AND METHODS
Tracer preparation
ICG was prepared in the operating room following preparation instructions of the institutional pharmacist. ICG (25 mg vials, purchased from Pulsion Medical Systems Munich, Germany) was diluted in 10 cc of sterile water for injection to yield a 2.5mg/ml (3.2 mM) stock solution.
Clinical trial
The study protocol (S1 and S2 les, online available) was approved by the Local Medical Ethics Committee of the Leiden University Medical Center (LUMC) on 27-06-2012 and was performed in accordance with the ethical standards of the Helsinki Declaration of 1975. Due to administrational error, trail registration was performed after the start of the study (date trial registration 11-09-2014; ISRCTN16945066). This non-randomised study adheres to the Transparent Reporting of Evaluations with Non-Randomised designs (TREND) guidelines (S3 le). The authors con rm that all ongoing and related trials for this intervention are registered. Because this study was set up as feasibility study, no formal sample size could be calculated. Determination of feasibility was expected after inclusion of 15 patients. In case apparent non-feasibility was observed, earlier termination of the study could be performed.
Eventually, ten patients presenting at the department of Gynaecological Oncology of LUMC between 14 October 2012 and 11 December 2013 suspected of either early stage ovarian cancer scheduled to undergo staging surgery or of advanced ovarian cancer scheduled to undergo cytoreductive surgery, were included. All surgical procedures were performed by laparotomy through a midline abdominal incision. All patients gave written informed consent. Exclusion criteria were pregnancy, severe renal insu ciency (GFR < 55 mL/ min/1.73 m2), or an allergy to iodine or ICG.
In the operating theatre, after opening of the abdominal cavity, 20 mg of ICG was administered intravenously as single bolus by the anaesthesiologist. The average time between administration of ICG and imaging of the rst lesion was 37 minutes. The last lesion was imaged on average 141 minutes post- administration of ICG. First the surgical eld was searched for metastases visible by the naked eye. After resection of the primary tumor, uterus and ovaries, the Mini-FLARE was used to identify NIR uorescent signals. When a uorescent