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临床试验/NCT04020523
NCT04020523撤回不适用

Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer

Assistance Publique - Hôpitaux de Paris0 个研究点开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No

研究概览

简要总结

Evaluation of advanced MRI acquisition techniques (perfusion and diffusion) to detect breast cancer. Two MR advanced sequences will be added to a standard breast MRI protocol for evaluation purpose.

详细描述

This is a prospective monocentric longitudinal study on a consecutive population of patients who require breast MRI as part of their course of care in the radiology department of the Tenon Hospital (3T MRI).

The standard protocol for breast MRI routinely performed in Tenon hospital consists of a set of MR acquisitions performed with contrast agent injection. The research consists of adding perfusion and diffusion sequences to the regular MR protocol. The addition of these sequences does not require a new injection of contrast medium.

Diagnosis of lesions after the breast MR exam will be performed using standard MR sequences as usual. According to the recommendations of SIFEM, the final diagnosis of the lesions will be made either by histological analysis of a biopsy performed as part of the patient's standard care pathway, or during patient's follow-up if a biopsy is not indicated (up to two years after breast MR exam).

The research will focus on evaluating the sensitivity and specificity of perfusion MRI sequence with or without diffusion MRI sequence compared to the sensitivity and specificity of the standard protocol.

For the perfusion sequence, the following data will be extracted: qualitative (shape of the contrast curve), semi-quantitative (elevation slope and asymptote of the curve) and quantitative by compartmental modeling (tissue perfusion, blood volume fraction, surface capillary permeability).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adult patient
  • •Patient who has signed a consent form to participate in the study
  • •Affiliated patient or beneficiary of a social security scheme
  • •Patient with an injected breast MR exam planned as part of her care pathway.

排除标准

  • •Patients under guardianship or curatorship
  • •Pregnant or breastfeeding patients
  • •Patients with contraindications to realization of an MR exam and an injected MR exam

研究组 & 干预措施

Patient with an injected breast MR exam

Experimental

干预措施: MRI sequence (Other)

结局指标

主要结局

Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No

时间窗: Day 1 at inclusion

to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity

Mammary lesions Visualization with a diffusion sequence

时间窗: Day 1 at inclusion

to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity

次要结局

  • Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion(Day 1 at inclusion)
  • Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one(Day 1 at inclusion)
  • Quantitative perfusion parameters : Enhancement Integral (EI (%))(Day 1 at inclusion)
  • Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))(Day 1 at inclusion)
  • Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))(Day 1 at inclusion)
  • Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))(Day 1 at inclusion)
  • Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)(Day 1 at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

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Advanced MR Techniques for Breast Cancer Detection | 临床试验