CE-MRI&CESM in Solid Breast Lesions | NCT04832191

Studies
CE-MRI&CESM in Solid Breast Lesions

NCT04832191

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 5, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Neoplasms

Interventions

CE-SM

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Apr 1, 2023Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Apr 2, 2021

First Submission Date that Met QC Criteria

Apr 2, 2021

First Posted Date

Apr 5, 2021Actual

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

Apr 2, 2021

Last Update Posted Date

Apr 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Basma Fawzy Mohamed Gad El-Rab, Assistant professor, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

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

Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Detailed Description

Breast cancer is the most common cancer in women, responsible for 23% of cancer in females worldwide (1).

Early detection and accurate diagnosis of breast cancer aims to reduce morbidity and mortality and have essential role in management and improved prognosis of breast cancer (2).

Mammography has been established as the imaging modality for screening and early detection of breast cancer; however, it is accused of having low sensitivity and specificity in women with dense breasts (3).

Contrast-enhanced MRI considered the gold standard method for diagnosis of breast cancer; but, it has many limitations as high cost, long examination time and limited availability (4,5).

Contrast-enhanced spectral mammogram (CESM) is considered now a relatively new imaging modality which can provide both anatomic and functional information of the breast lesion similar to MRI (6).

CESM like contrast-enhanced MRI (CE-MRI) is used to detect angiogenesis of the lesion in the mammography suite. It includes high- and low-energy images during a single compression after contrast injection (7).

The advantage of CESM over MRI is that it is less expensive and easier to perform with shorter examination time. Also, the higher sensitivity of MRI is plagued by numerous false-positive foci of enhancement (8).

Also, CESM can replace MRI in case of patient contraindicating for MRI as patients with pacemakers, aneurysm clips or metal implants, or severe claustrophobia (7).

So, our study aims to determine the value of CESM and answer the question of does CESM could replace CE-MRI in diagnosing breast cancer? so,our study aimed to assess the accuracy of CESM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CE-SM	Device	contrast enhanced spectral mammography &contrast enhanced magnetic resonance imaging		CE-MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparison between accuracy of CESM and CE-MRI in diagnosing breast cancer.	Measurement of sensitivity, specificity and predictive values of CESM and CE-MRI in diagnosing breast cancer.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have previously undergone mammography (MG) and ultrasound and have a solid (BIRADs III and more) breast lesion.

Exclusion Criteria:

Cystic breast lesions
BIRADs I and II breast lesions(benign)
Pregnancy
History of allergic reaction to iodinated contrast agent
Renal insufficiency
Other contraindications to MRI include pacemaker, claustrophobia or metal prosthesis.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients presented clinically with solid breast lesions.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Basma Fawzy Mohamed, assistant lecturer	Contact	01146393169		bfawzy1@gmail.com
Hazem Abou Zaid Yousef, Assistant professor	Contact	01005075888		Bozaidhazz@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29983379	Background	Zhu X, Huang JM, Zhang K, Xia LJ, Feng L, Yang P, Zhang MY, Xiao W, Lin HX, Yu YH. Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Oct;18(5):e985-e995. doi: 10.1016/j.clbc.2018.06.003. Epub 2018 Jun 15.
27687829	Background

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