CE-MRI&CESM in Solid Breast Lesions

April 2, 2021 updated by: Basma Fawzy Mohamed Gad El-Rab, Assiut University

1.3 Role of Contrast-enhanced Mammography and Dynamic Contrast-enhanced MRI in the Assessment of Solid Breast Lesions

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Basma Fawzy Mohamed, assistant lecturer
  • Phone Number: 01146393169
  • Email: bfawzy1@gmail.com

Study Contact Backup

  • Name: Hazem Abou Zaid Yousef, Assistant professor
  • Phone Number: 01005075888
  • Email: Bozaidhazz@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients presented clinically with solid breast lesions.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-MRI&CESM in breast lesions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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