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

Active, not recruiting

• Conditions: Breast LN

• Registration Number: NCT06744101
• Lead Sponsor: Superior University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-28
• Primary Completion: 2024-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 108

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

*

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	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

Trial Locations

Locations (1)

563-B peoples colony 1 main satiana road Faisalabad; 🇵🇰 Faisalābad, Punjab, Pakistan