New Mammographic Techniques Versus MRI in Assessment of Breast Lesions (CEDM&DBTVSMR)

October 16, 2023 updated by: Marwa A Haggag, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

40

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

FEMALE

Description

Inclusion criteria

  1. Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
  2. Clinical indication for MRI breast imaging.
  3. 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
contrast enhanced mammography, tomosynthesis and MRI
CEDM and tomosynthesis versus MRI
Diagnostic test: contrast enhanced digital mammography, tomosyntheis and MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 1year
diagnostic
1year

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol

IPD Sharing Time Frame

1year

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Study Data/Documents

  1. Study Protocol
    Information identifier: Cairo unversity
    Information comments: upon requirement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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