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Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI

NCT02608281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-08-11

No results posted yet for this study

Summary

Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be compared for both modalities.

Conditions

  • Breast Cancer Diagnosis

Interventions

DEVICE

CONTRAST ENHANCED DUAL ENERGY (CEDEM)

The CEDEM application requires the intravenous injection of iodide contrast agents. For each projection view (CC, MLO) a low and a high energy x-ray image will be acquired after Iodine based contrast medium administration. Patient will undergo CE MRI procedure.

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Siemens Healthcare QT

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608281 on ClinicalTrials.gov