Effectiveness of Introducing Ultra-High B-Value Diffusion... | NCT06970288

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

NCT06970288

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

May 14, 2025Actual

Enrollment

85Estimated

Phase

Not provided

Conditions

Breast Carcinoma

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2025Estimated

Primary Completion Date

Nov 15, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

May 6, 2025

First Submission Date that Met QC Criteria

May 6, 2025

First Posted Date

May 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2025

Last Update Posted Date

May 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women in childbearing age who have a suspicious breast lump

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Mohamed Aly	Contact	+201273726233		ahmedaly@med.asu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University	Recruiting	Cairo	Abbasia		Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided