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

NCT ID: NCT06970288

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-10

Study Completion Date

2026-12-30

Brief Summary

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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

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Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, Abbasia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Mohamed Aly

Role: CONTACT

+201273726233

Facility Contacts

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Ahmed Mohamed Aly

Role: primary

+201273726233

Other Identifiers

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MD45/2025

Identifier Type: -

Identifier Source: org_study_id

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