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临床试验/NL-OMON20184
NL-OMON20184Other不适用

Visualizing breast lesions with the second generation Twente photoacoustic mammoscope (PAM 2)

Prof. dr. ir. Wiendelt Steenbergenon behalf of:Biomedical Photonic ImagingMIRA InstituteUniversity of Twente0 个研究点目标入组 130 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
Other
发起方
入组人数
130

研究概览

简要总结

n/a

研究设计

研究类型
Observational

入排标准

入选标准

  • Adult women who come to the mammapoli with a lesion suspicious for malignancy, which, after clinical investigation and diagnostic imaging is classified as BIRADS 4 or 5, or BIRADS 2 or 3;
  • - Subjects who are fully competent to give informed consent.
  • For healthy volunteer measurements:
  • - Adult women;
  • - Subjects who are fully competent to give informed consent.

排除标准

  • - Subjects who have a cup size of D or larger OR subjects for whom the biggest size breast supporting cup is too small;
  • - Subjects who had a breast biopsy in the 6 months prior to this study;
  • - Subjects with bloody discharge, ulcers or wounds on the breast;
  • - Subjects with a history of surgery (including cosmetic surgery) or radiation
  • therapy on the breast;
  • - Subjects who are currently undergoing chemotherapy.
  • For healthy volunteer measurements:
  • - Subjects who have a cup size of D or larger OR subjects for whom the biggest size breast supporting cup is too small;
  • - Subjects who have symptoms of breast cancer such as a palpable mass which
  • might be attributed to breast cancer;
  • - Subjects who have had (a) benign breast lesion(s) in the past;
  • - Subjects who have had breast cancer in the past;
  • - Subjects who had a breast biopsy in the 6 months prior to this study;
  • - Subjects with blood discharge, ulcers or wounds on the breast;
  • - Subjects with a history of surgery (including cosmetic surgery) or radiation
  • therapy on the breast;
  • - Subjects who are currently undergoing chemotherapy.

研究者

发起方
Prof. dr. ir. Wiendelt Steenbergenon behalf of:Biomedical Photonic ImagingMIRA InstituteUniversity of Twente

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