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临床试验/EUCTR2017-003089-29-AT
EUCTR2017-003089-29-AT进行中(未招募)1 期

Measuring hallmarks of cancer for non-invasive characterization of breast lesions by simultaneous multiparametric 18F-ethylcholine PET- MRI – an exploratory study - Measuring hallmarks of cancer for non-invasive breast cancer diagnosis by 18F-ethylcholine PET-MRI

Medical University of Vienna, Department of Biomedical Imaging and Image-guided Therapy0 个研究点目标入组 100 人开始时间: 2017年10月27日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Breast lesion classified as suspicious on conventional imaging (ACR BI-RADS 4 or 5);
  • Age > 18 years;
  • No previous biopsy in the site of the lesion at the time of PET-MRI;
  • Following histopathological confirmation of the lesion by biopsy or 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 70
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • Unstable or non-compliant patients;
  • Pregnant or breast-feeding patients;
  • Radiation therapy within the last six months or surgical interventions less than 12 weeks
  • before PET-MRI examination;
  • Known contraindication to the intravenous administration of MR contrast agents or MRI
  • examination;
  • Known contraindication to the intravenous administration of 18F-methylcholine; • Acute or chronic renal insufficiency;
  • Pre- or post-transplant patients.

研究者

发起方
Medical University of Vienna, Department of Biomedical Imaging and Image-guided Therapy

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