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临床试验/NCT06744101
NCT06744101进行中(未招募)不适用

Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions

Superior University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年2月28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)
入组人数
108
试验地点
1
主要终点
Sensitivity and Specificity

研究概览

简要总结

This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.

详细描述

Diffusion Weighted MRI, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. This research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of DW-MRI and US. The findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with suspected breast lesions
  • Breast feeding woman
  • Referred for MRI examination.
  • Age 18 years or older
  • Ability to provide informed consent.

排除标准

  • Contraindications to MRI or contrast agent
  • Previous breast Implant
  • Early Pregnancy
  • Exclusion criteria

结局指标

主要结局

Sensitivity and Specificity

时间窗: 12 Months

* Ultrasonography (USG): BI-RADS classification. * Diffusion Weighted MRI (DWI): Apparent Diffusion Coefficient (ADC) values. * Scales/Measurements: * Sensitivity (%): Formula: (True Positives) ÷ (True Positives + False Negatives) × 100 * Specificity (%): Formula: (True Negatives) ÷ (True Negatives + False Positives) × 100

次要结局

未报告次要终点

研究者

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

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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