跳至主要内容
临床试验/NL-OMON20835
NL-OMON20835尚未招募不适用

A new device (PAMMOTH) for hybrid photoacoustic and ultrasound mammoscopy to evaluate screening-detected abnormalities in the breast

niversity of Twente0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • Healthy volunteers:
  • - Adult women;
  • - Subjects who are fully competent to give informed consent.
  • Extra criteria for patients:
  • - Adult women who present at the Centre for Mammacare with an anomaly in the breast, which, after clinical investigation and diagnostic imaging is suspect to be of an ICNST, ILC, DCIS, FA or cyst;
  • - Subjects who are fully competent to give informed consent.

排除标准

  • Healthy volunteers:
  • - Subjects with a (history of) breast disease;
  • - Subjects with a tattoo or irremovable piercings on/in the breast;
  • - Subjects who are pregnant or who are breastfeeding.
  • - Subjects with a known allergy for PVC
  • - Subjects who are not physically capable of climbing on the examination bed, who’s breast are too big to fit in the cup sizes or are not capable to lay still in prone position for the requested examination time.
  • Criteria for patients:
  • - Subjects who had a breast biopsy in the 6 months prior to this study;
  • - Subjects with bloody discharge, breast ulcers or -wounds;
  • - Subjects with a history of surgery (including cosmetic surgery) or radiation therapy on the breast;
  • - Subjects who are currently undergoing chemotherapy;
  • - Subjects with a tattoo or irremovable piercings on/in the breast;
  • - Subjects who are pregnant or who are breastfeeding;
  • - Subjects with contra-indication for breast MRI.
  • - Subjects with a known allergy for PVC
  • - Subjects who are not physically capable of climbing on the examination bed, who’s breast are too big to fit in the cup sizes or are not capable to lay still in prone position for the requested examination time.

研究者

发起方
niversity of Twente

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