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临床试验/NCT05892380
NCT05892380尚未招募不适用

The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions

Fudan University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
试验地点
1
主要终点
Comparison between the diagnostic performance of【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,

研究概览

简要总结

This study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of clinical work.

详细描述

Full sequence of MRI scan is:

MR scan protocol:

  1. Magnetic fields and coils: Use MR scanners with high fields of 1.5 T and above with dedicated breast coils.
  2. Scanning position: prone position with bilateral breasts naturally draped over the center of the breast coil. The position should ensure that all breast tissue is located in the coil, the skin and breast are not folded, the bilateral breast is symmetrical, the nipple is perpendicular to the ground, and the midline of the sternum is located in the middle line of the coil.
  3. Scanning sequence and parameters: T1WI non-fat suppressed sequence, T2WI fat suppressed sequence, dynamic five-phase enhanced T1WI fat suppressed sequence, and diffusion weighted imaging (DWI); delayed sagittal T1W1 fat suppressed sequence.

Imaging parameters: the thickness of the scanned layer should be ≤3 mm, the resolution within the layer should be <1.5 mm, and the single scan time should be <2 min.

Enhancement scan: Gadobutrol used as the contrast agent, and the injection dose was 0.1 ml/kg, which was injected through the elbow vein at a rate of 2-3 mL/s using a pressure syringe, and 10-20 mL of saline was injected into the tube at the same rate after the contrast agent injection. The T1WI sequences before and after enhancement were preferably fat-suppressed and bilateral mammary glands were imaged simultaneously, and subtraction treatment was recommended. The recommended duration of delayed enhancement scan is 7 min, not less than 5 min.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with breast lesions detected by ultrasound and mammography that cannot be characterized
  • Patients who were consecutively included in our hospital for breast MRI without treatment
  • Underwent preoperative full-protocol breast MRI
  • Pathological results are available, of which benign lesions can be determined by follow-up

排除标准

  • Poor MRI image quality
  • Patients who have been received the biopsy

结局指标

主要结局

Comparison between the diagnostic performance of【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,

时间窗: 2 years

Comparison of AUC, sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) between【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,

次要结局

  • Comparison of the interpretation time of abbreviated and full protocol(2 years)
  • Comparison of the scan time of abbreviated and full protocol(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yajia Gu, MD

Director of Radiology

Fudan University

研究点 (1)

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