New Mammographic Techniques Versus MRI in Assessment of B... | NCT06089148

Studies
New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

NCT06089148

Sponsor

Cairo University

Status

Completed

Last Update Posted

Oct 18, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Breast Diseases

Interventions

contrast enhanced digital mammography, tomosyntheis and MRI

Countries

Not provided

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 2, 2023

First Submission Date that Met QC Criteria

Oct 16, 2023

First Posted Date

Oct 18, 2023Actual

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

Oct 16, 2023

Last Update Posted Date

Oct 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Detailed Description

Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
contrast enhanced mammography, tomosynthesis and MRI		CEDM and tomosynthesis versus MRI	Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
contrast enhanced digital mammography, tomosyntheis and MRI	Diagnostic Test		contrast enhanced mammography, tomosynthesis and MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer	diagnostic	1year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
Clinical indication for MRI breast imaging.
No histologically proven cancer before enrollment. Exclusion criteria

1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

FEMALE

Sampling Method

Probability Sample

ID	Type	URL	Comment
Cairo unversity	Study Protocol	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

study protocol

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

1year

Access Criteria

http://www.medicine.cu.edu.eg/index.php/en/

URL

http://www.medicine.cu.edu.eg/index.php/en/

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided