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临床试验/NCT05006196
NCT05006196进行中(未招募)不适用

Contrast-Free Magnetic Resonance Imaging for Breast Disease

Perspectum2 个研究点 分布在 1 个国家目标入组 1,030 人开始时间: 2021年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Perspectum
入组人数
1,030
试验地点
2
主要终点
Determine the diagnostic performance of a non-contrast MRI in breast disease

研究概览

简要总结

Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.

详细描述

It is widely recognised that mammography is highly sensitive for detecting breast lesions and a valuable tool for early detection of breast cancer, especially in post-menopausal women with non-dense breast tissue. On post-menopausal non-dense breast tissue, mammography is 90% effective at identifying breast tumours. However, for dense breast tissue, the sensitivity falls to 67%. This means that for women with dense breast tissue, which includes almost all pre-menopausal women and many post- menopausal women, mammography misses one third of tumours.

MRI is the imaging method of choice for detecting breast cancer in women with dense breast tissue however the standard MRI for breast cancer investigation typically uses gadolinium contrast agent. This method is called dynamic contrast enhanced (DCE) MRI and identifies localised regions of (neo)vascularity, which indicates a cancerous lesion. Although DCE can provide valuable information about the tissue, it is often not performed well, is poorly tolerated by patients, and adds additional time to the scan protocol.

Perspectum conducted a recent study demonstrating that liver cancer lesions can be identified using quantitative T1 maps calculated form multiparametric MRI data. Applying this MRI method to breast imaging, would potentially provide a method of identifying breast cancer lesions without using a contrast agent, reducing the scan time and eliminating the need for an intravenous contrast.

The aim of this study is to apply quantitative multiparametric MRI techniques to the area of breast imaging with the aim of developing a contrast-free MR scan which can diagnose the spectrum of breast disease referred to a secondary care breast clinic, including in women with dense breasts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Female 30 years of age and over
  • Participant has been referred to a secondary care breast screening clinic.
  • Participant is willing and able to give informed consent for participation in the investigation.

排除标准

  • The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
  • Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

结局指标

主要结局

Determine the diagnostic performance of a non-contrast MRI in breast disease

时间窗: 36 months

Mapping multi-parametric algorithms and assessing diagnostic performance compared to standard of care using area under the receiver operative curve (AUROC)

次要结局

  • Qualitatively assess the participant experience of identifying breast disease using non-contrast MRI(36 months)

研究者

发起方
Perspectum
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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