Towards plannable breast surgery: diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node (MIB study) - Microbubbles and Iodine seeds in Breast cancer: MIB study

niversity Medical Center Utrecht0 个研究点目标入组 120 人开始时间: 2012年7月24日最近更新: 2014年8月11日

适应症

试验速览

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•- Females, aged 18 years or older;
•- Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy;
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Male patients;
•- Histologically or cytologically proven axillary lymph node involvement;
•- Recurrent disease;
•- Indication for ALND;
•- Pregnancy or lactation;
•- Sentinel lymph node biopsy after neoadjuvant treatment;
•- Recent acute coronary syndrome or unstable ischemic heart disease*;
•- Severe lung disease* and shortness of breath;
•- Unstable neurologic disease, acute endocarditis, artificial heart valves, acute systemic infection, tromboembolic disease, advanced liver or kidney failure;
•- Mentally incompetent patients.
•* SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.

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