Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06744101

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast LN

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

563-B peoples colony 1 main satiana road Faisalabad

Faisalābad, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Exclusion criteria

*

Treatment and study plan

Evaluate the effectiveness of Diffusion Weighted MRI (DWI) in detecting breast lesions.

Radiation

Assess the sensitivity, specificity, and diagnostic accuracy of DWI compared to Ultrasonography (USG) for benign and malignant lesions.

Compare Sensitivity and Specificity of DWI and USG

Radiation

Analyze which modality performs better in lesion detection based on sensitivity and specificity.

Primary outcomes

  1. Sensitivity and Specificity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.