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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06744101

Enrollment

108

Registered

2024-12-20

Start date

2024-02-28

Completion date

2025-03-01

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast LN

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.

Interventions

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

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

RADIATIONCompare Sensitivity and Specificity of DWI and USG

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026