Effectiveness of Introducing Ultra-High B-Value Diffusion-Weighted Imaging as a Modified Abbreviated Protocol for Breast Cancer Detection

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT06970288
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to evaluate the added value of non-contrast abbreviated MRI protocol featuring ultra-high B value Diffusion Weighted Imaging to detect, characterize suspicious breast lesions and avoid using contrast.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study Start: 2025-05-10
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-11-15
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• • Women with suspicious breast mass (BIRADS 4a)

  • High risk women (Positive family history)
  • Women with suspicious axillary lymph nodes by Ultrasound
  • Women with dense breasts coming for MRI imaging.

Exclusion Criteria

• • Contraindications to MRI

  • Pacemaker, cochlear implant, claustrophobia, ocular implants
  • Contraindications to contrast administration:
  • Elevated kidney functions
  • Women who haven't undergone reliable Mammogram & Ultrasound
  • Women with prior treatment or intervention (e.g. biopsy)
  • Patients' refusal.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the capability of detecting suspicious breast lesions using non-contrast enhanced MRI protocol featuring ultra-high B-value	20 months

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt