NCT04832191

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 2, 2021

Last Update Submit

April 2, 2021

Conditions

Breast Neoplasms

Keywords

CE-SM /CE-MRI/solid breast lesions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

CE-SMDEVICE

contrast enhanced spectral mammography \&contrast enhanced magnetic resonance imaging

Also known as: CE-MRI

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presented clinically with solid breast lesions.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29983379BACKGROUND

  • Li L, Roth R, Germaine P, Ren S, Lee M, Hunter K, Tinney E, Liao L. Contrast-enhanced spectral mammography (CESM) versus breast magnetic resonance imaging (MRI): A retrospective comparison in 66 breast lesions. Diagn Interv Imaging. 2017 Feb;98(2):113-123. doi: 10.1016/j.diii.2016.08.013. Epub 2016 Sep 26.

    PMID: 27687829BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Basma Fawzy Mohamed, assistant lecturer

CONTACT

01146393169bfawzy1@gmail.com

Hazem Abou Zaid Yousef, Assistant professor

CONTACT

01005075888Bozaidhazz@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 5, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

April 5, 2021

Record last verified: 2021-04