Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
CEDEM
Clinical Study to Evaluate Diagnostic Accuracy of Low Dose Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 11, 2017
August 1, 2017
1.8 years
October 9, 2015
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of contrast enhanced dual energy mammography for breast cancer diagnosis
Difference in accuracy of 11% comparing a 4-view contrast-enhanced dual energy imaging to CE-MRI assuming 11% discordant rate in the diagnosis
24 months
Secondary Outcomes (1)
sensitivity, specificity and the lesion-level ROC area.
24 months
Study Arms (1)
CEDEM
OTHERdiagnostic contrast enhanced Dual Energy mammograms after Iodine based contrast media administration compared to CE MRI
Interventions
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.
Eligibility Criteria
You may qualify if:
- Females at least 21 years of age or older
- A screening mammogram classified as BI-RADS® 0, 4 or 5 followed by a diagnostic CE-MRI and a histological verification of a given lesions either by needle biopsy or open surgery
- Signed informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study
You may not qualify if:
- Pregnant or possible pregnant as well as lactating women
- Have mammographic evidence of previous breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident on the mammogram
- Breast implants
- Patients who will undergo neo-adjuvant chemotherapy (BI-RADS 6)
- Inmates or mentally disabled patient.
- Renal insufficiency or contrast agent allergy
- Patients who participated in other clinical studies within the last 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Siemens Healthcare QTlead
- Medical University of Viennacollaborator
Study Sites (1)
Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2015
First Posted
November 18, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08