Clinical trial · Interventional
Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
Clinical Study to Evaluate Diagnostic Accuracy of Low Dose Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Diagnosis | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONTRAST ENHANCED DUAL ENERGY (CEDEM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CEDEM
- description
- diagnostic contrast enhanced Dual Energy mammograms after Iodine based contrast media administration compared to CE MRI
- interventionNames
- Device: CONTRAST ENHANCED DUAL ENERGY (CEDEM)
Primary outcomes (1)
- measure
- Diagnostic accuracy of contrast enhanced dual energy mammography for breast cancer diagnosis
- timeFrame
- 24 months
- description
- Difference in accuracy of 11% comparing a 4-view contrast-enhanced dual energy imaging to CE-MRI assuming 11% discordant rate in the diagnosis
Secondary outcomes (1)
- measure
- sensitivity, specificity and the lesion-level ROC area.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available