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RecruitingNCT06970288Updated May 14, 2025

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

An observational study in Breast Carcinoma, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
85
Ages
30 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Carcinoma

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 85 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women in childbearing age who have a suspicious breast lump

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To evaluate the capability of detecting suspicious breast lesions using non-contrast enhanced MRI protocol featuring ultra-high B-value

    Time frame: 20 months

07

Study locations

1 of 1 sites recruiting
  • Ain Shams University
    Cairo, Abbasia, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06970288
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
May 14, 2025
Start date
May 10, 2025 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 14, 2025

Study contacts

Ahmed Mohamed Aly
Contact
ahmedaly@med.asu.edu.eg
+201273726233

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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