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Clinical Trials/NCT06744101
NCT06744101
Active, not recruiting
Not Applicable

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

Superior University1 site in 1 country108 target enrollmentFebruary 28, 2024
ConditionsBreast LN

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast LN
Sponsor
Superior University
Enrollment
108
Locations
1
Primary Endpoint
Sensitivity and Specificity
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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