跳至主要内容
临床试验/NL-OMON54760
NL-OMON54760招募中不适用

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

niversiteit Twente0 个研究点目标入组 160 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
招募中
发起方
入组人数
160

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

年龄范围
18 至 99(—)

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. (only in Medisch Spectrum
  • - 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
niversiteit Twente

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