MOLECULAR FLUORESCENCE-GUIDED SURGERY USING BEVA800 FOR THE ASSESSMENT OF TUMOR MARGINS DURING BREAST CONSERVING SURGERY OF PATIENTS WITH PRIMARY BREAST CANCER (MARGIN-II) - MARGIN-II

Bracco Imaging Spa0 个研究点目标入组 51 人开始时间: 2018年11月23日最近更新: 2022年8月8日

适应症

试验速览

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•Female participant =18 years of age;
•Is able to give written informed consent and is willing to comply with the protocol requirements;
•Is scheduled to undergo breast conserving surgery.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Is a pregnant or lactating female. Exclude the possibility of pregnancy:
•by testing on site at the institution (serum or urine ßHCG) within <24 hours> prior to the start of investigational product administration,
•by surgical history (e.g., Tubenligatur oder Hysterektomie),
•post-menopausal with a minimum 1 year without menses;
•Has any known allergy to one or more of the ingredients of the investigational product or the bevacizumab;
•Has received or is scheduled to receive neo-adjuvant chemo- and/or radiotherapy;
•Has received an investigational compound and/or medical device within 30 days before admission into this study;
•Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations;
•Is determined by the Investigator that the subject is clinically unsuitable for the study

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